MDT STR 801 URM AD-PED ST codici a listino_rev7 1/4

(1)

Via Jonio, 43 – 75100 MATERA



0835.268807/0835.259641



0835.309548 – www.betafin.it  betafin@betafin.it Capitale sociale € 104.000,00 – REA n. 34953 – R.I./Partita I.V.A./Cod. Fisc. 00129500773

Pag. 1 di 1

OFFERTA ECONOMICA SENZA PREZZI Spett.le

I.R.C.C.S. – C.R.O.B.

Via Padre Pio, 1

85028 Rionero in Vulture (PZ)

Prot.n.3639P412.20pg

OGGETTO: RdO2603590 - Procedura negoziata sul MEPA per la fornitura Dispositivi medici necessari alla U.O. Anestesia, Rianimazione e Terapia Intensiva per la durata di un anno.

Offerta economica LOTTO 19.

La ditta BETAFIN SPA con sede in Matera, Via Jonio n. 43, tel. 0835.268807 / 0835.269641, fax 0835.309548, Cod.

Fisc. e P. IVA 00129500773, iscritta alla C.C.I.A.A. di Matera al n. 00129500773 dal 19/02/96, REA n. 34953 in data 06/10/78, rappresentata dal sig. Carmine Salerno, in qualità di Presidente del CDA, sottopone la propria migliore offerta per quanto in oggetto così come di seguito riportato.

Q.tà richiesta

Codice

offerto Descrizione BD/RDM

CND

Conf.

(pz)

Prezzo unitario

offerto Prezzo totale offerto

1800 309/6310

Unità respiratoria manuale per adulti (pallone 2lt) con carica dall'alto dei gas.

BD/RDM: 1180502 CND: R03020201 10

IMPORTO TOTALE DELLA FORNITURA – LOTTO 19:

CONDIZIONI DI FORNITURA

- Pagamento: 60 gg. data fattura;

- Prezzi IVA esclusa 22% a Vs. carico;

- Imballo, trasporto e consegna: a ns. carico c/o Vs. sede entro 10 gg. data ordine;

Matera, 28/07/2020.

(2)

Scheda Tecnica

Unità respiratorie manuali sterili

CFN: vedi sotto

MDT STR 801 URM AD-PED ST codici a listino_rev7 1/4

DATI GENERALI

Fabbricante: Covidien llc, 15 Hampshire Street, MA 02048 Mansfield, USA

Mandatario: Covidien Ireland Limited, IDA Business & Technology Park, Tullamore, Ireland

Società autorizzata alla commercializzazione in Italia:

Medtronic Italia S.p.A.

Via Varesina, 162 20156 Milano (MI) Classificazione CE (D.L.vo 46/97

attuazione Dir. CE 93/42, D.L.vo 507/92 attuazione Dir. CE 90/385):

Classe IIa

Allegati secondo cui è stato certificato il dispositivo:

Allegato II/2

N° Certificato Marcatura CE: G1 077790 0060

N° Dichiarazione di Conformità: DoC - 10067219 Breathing System Class IIa

GMDN: 62728

CND: R03020201

Numero di repertorio: vedi sotto

(3)

MDT STR 801 URM AD-PED ST codici a listino_rev7 2/4 Descrizione: L'Unità Respiratoria Manuale (URM) è un presidio

monouso realizzato in PVC, morbido, trasparente, di grado medico. Esso consente la somministrazione manuale di miscele gassose secondo la tecnica di ventilazione comunemente denominata "va e vieni".

L'URM è composta da un pallone, con capacità comprese tra 0,5 e 3 litri, da un connettore a "L" cui giungono gas freschi mediante un apposito tubo corrugato e da una valvola di scarico denominata A.P.L. a controllo geometrico. L’unità respiratoria manuale può essere corredata, inoltre, da una valvola di sovrapressione magnetica pre-calibrata con apertura automatica a circa 40 cmH2O.

La valvola APL sostituisce il sistema di regolazione a vite con due settori a geometria variabile, permettendo una definizione molto precisa della pressione durante la fase inspiratoria. Il risultato è ottenuto mediante la rotazione di un piano inclinato, che incrementa linearmente la sezione di uscita dei gas ventilatori, così che la pressione all'interno del circuito dipende semplicemente dal grado di apertura della valvola.

Per permettere il collegamento dell'URM alle diverse fonti di gas il prodotto viene fornito con una serie di connettori universali.

I valori di compliance sono conformi a quanto richiesto dalla norma ISO 5367.

Le connessioni sono conformi alla normativa ISO 5356 e possono così configurarsi:

Al paziente: 22M/15F

Alla fonte dei gas: da 5 a 8Flex, da 8 a11Flex, 15M , 22F Allo scarico dei gas: 15M 30M

Destinazione d’uso: Circuito respiratorio per Rianimazione (unità di Terapia Intensiva e Reparti di Pronto Soccorso) e/o Anestesia nelle versioni adulta, pediatrica e neonatale.

Il circuito contiene una valvola APL.

L’Unità Respiratoria Manuale (URM) è indicata principalmente per la rianimazione di pazienti. Viene anche utilizzata per l’induzione di anestesia e/o per supporto respiratorio in periodo post-anestetico

Materiali costituenti il Dispositivo Medico a diretto contatto con il paziente:

Tubo: PVC

Raccordi: ABS e PVC Valvola: ABS

Pallone: chloroprene

Controlli di Qualità:

Tutti i prodotti vengono collaudati al 100% e superano la prova di tenuta meccanica.

Il prodotto sterile viene sottoposto a ciclo di

sterilizzazione con gas sterilizzante Ossido di Etilene; tale

ciclo è opportunamente validato e monitorato in accordo

(4)

MDT STR 801 URM AD-PED ST codici a listino_rev7 3/4 procedure interne in uso. Il prodotto viene rilasciato sul mercato al termine del ciclo di sterilizzazione con valori di residuo di Ossido di Etilene e di cloridrina etilenica conformi alla normativa di riferimento ISO 10993-7.

Tollerabilità:

Il prodotto non riscontra incompatibilità verso le sostanze con le quali viene a contatto durante il normale utilizzo.

Controindicazioni ed avvertenze: Dal punto di vista della stabilità chimico-fisica il prodotto ed il materiale di cui è realizzato non subiscono alterazioni nel tempo. L’esposizione a raggi solari o fonti artificiali di luce non variano la struttura del prodotto, a condizione dell’integrità della confezione.

Il prodotto è da intendersi monouso, non risterilizzare né riusare.

Durata massima di impiego: 72h.

Latex Free: SI

Contiene Ftalati: Vedi sotto

Confezionamento primario del DM

Modalità di smaltimento: Quando il dispositivo viene eliminato adottare adeguate precauzioni per lo smaltimento che deve avvenire secondo la legislazione nazionale e le normative ospedaliere applicabili per i rifiuti biologicamente pericolosi.

Confezionamento: Il singolo prodotto viene confezionato mediante un imballo termoformato realizzato da uno strato di polietilene a bassa densità ed una pellicola di carta laccata grigliata. La carta laccata grigliata ha una particolare resistenza meccanica ed una costante permeabilità ai gas:

essa consente il passaggio del gas sterilizzante ed un’ottima saldatura sigillante e facilmente pelabile. La pellicola termoformata è in polietilene trasparente, prodotto approvato per alimenti e per uso medico, certificato secondo le normative vigenti. Il polietilene adottato, in base alle necessità, può essere del tipo a bassa densità tradizionale o polietilene lineare a bassa densità: entrambe le tipologie sono approvate per il confezionamento di prodotti alimentari e per uso medico.

I materiali prevalenti costituenti il confezionamento primario del DM necessitano di condizioni speciali di smaltimento:

No

Tipo confezionamento: SINGOLO

Quantità per confezione: 10 Each Dati di sterilizzazione

Sterile: Sì

Metodi di sterilizzazione: Ossido di etilene

Periodo massimo di utilizzo (mesi): 60

(5)

MDT STR 801 URM AD-PED ST codici a listino_rev7 4/4

Monouso: Si

*

per maggiori informazioni sulla configurazione dei circuiti fare sempre riferimento al disegno tecnico specifico.

CFN Descrizione* Contiene

Ftalati

Numero di Repertorio

309/13157 URM adulti ( Pallone 3 litri) - carica laterale tubo

ingresso gas 180 cm NO 1180451

309/6310 URM adulti (Pallone 2 litri )- carica dall’alto – tubo

ingresso gas 180 cm NO 1180502

309/6612 URM adulti (Pallone 2 litri) - carica laterale – tubo

ingresso gas 180 cm NO 1172286

309S14219

URM pediatrica (Pallone 1 litro) - valvola APL e tubo

ingresso gas 180 cm NO 1767275

(6)

Covidien llc

15 Hampshire Street Mansfield, MA 02048 USA

(formerly: Nellcor Puritan Bennett L.L.C., a division of Tyco Healthcare Group LP)

Covidien Ireland Limited

IDA Business & Technology Park Tullamore, Ireland

TÜV SÜD Product Services GmbH Ridlerstrasse 65

80339 Munich Germany 0123

Declaration of Conformity

Document #/Revision #: 10067219 Revision BE Product/Family Name: Breathing System

Classification Rationale: Class IIa, rule 2 (Part 2.2, Schedule 2 of Australian Legislation) EU Conformity Assessment Route: Annex II excluding (4)

Standards Applied: Please refer to section 4 of the Technical File Start of CE Marking: 11/1995

Covidien llc declares under our sole responsibility that the above product(s) to which this declaration relates, and which bear(s) the CE Marking, is (are) in conformity with the Essential Requirements of EC Directive 93/42/EEC of 14 June 1993, as amended by 2007/47/EC of the European Parliament and of the Council, concerning medical devices, which allows their free distribution, sale and circulation in the European Union (EU); they comply with the provisions of the defined regulatory requirements and which comply with the referenced standards, as stated above.

This declaration is made in accordance with the requirements of Clause 1.8 of Schedule 3 of the Australian Therapeutic Goods (TGA) Medical Device Regulations 2002, relating to the devices stated in Schedule I of this document.



All supporting documentation is retained by the manufacturer.



As required by the above Directive, this Declaration is supported by



EC Certificate: MDD Annex II excluding (4), G1 077790 0060 Rev. 00, Reference P/N 10069299, issued by TÜV SÜD Product Services GmbH, Ridlerstrasse 65, 80339 Munich Germany, on 2020-06-29.



Quality System Certificate: Q5 077790 0066 Rev. 00, Reference P/N 10069298, issued by Quality System TÜV SÜD Product Services GmbH, Ridlerstrasse 65, 80339 Munich Germany, on 2020-06-12.



This Declaration of Conformity is applicable to all of the medical devices referenced in Schedule I, manufactured by Covidien llc and/or produced under its certified Quality System control. Products referenced in Schedule I can be traced by means of the related product identification referenced in the relevant labeling (i.e.: lot number, serial number, etc.).



Each kind of medical device to which the Full Quality Assurance Procedures have been applied complies with the applicable provisions of the essential requirements/principles, the classification rules, at each stage, from the design of the device until its final inspection before being supplied.

This Declaration shall be retained for a period of the lifetime of the medical device (LMD) + 1 year or minimum of 15 years once the record is obsoleted or superseded.

Date of Issue: 30 June 2020

Place of Issue: Boulder, CO USA

Signature: __________________________________________________________

Name/Title Ashley Johnston, Manager, Regulatory Affairs RI

(7)

Declaration of Conformity for Breathing System

Medical Device

Part Number Description Class/

Rule GMDN Code and Term Anaesthesia & Intensive Care

260P25778 Breathing Circuit with Filter 1-Way Valve IIa/rule 2 37021/37704/37705/37706 285/25035 Adult Breathing Circuit with Exhalation Valve

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 285/25038 Adult Heated Circuit with Exhalation Valve Pressure

Monitoring Line IIa/rule 2 37021/37704/37705/37706

285/25067 Adult Filtered Circuit with Exhalation Valve Pressure

Monitoring Line, Filter HME IIa/rule 2 37021/37704/37705/37706

285/25069 Adult Breathing Circuit IIa/rule 2 37021/37704/37705/37706

285/25154 Adult Breathing Circuit with Exhalation Valve

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 285/25216 Adult Breathing Circuit with Aerosol O2 Mask

Nebulizer, 1-Way Valve IIa/rule 2 37021/37704/37705/37706

285/25217 Adult Breathing Circuit 1-Way Valve IIa/rule 2 37021/37704/37705/37706 285/25314 Adult Breathing Circuit with Exhalation Valve IIa/rule 2 37021/37704/37705/37706

285/25381 Adult Breathing Circuit 1-Way Valve IIa/rule 2 37021/37704/37705/37706 285/25390 Adult Breathing Circuit Mouthpiece IIa/rule 2 37021/37704/37705/37706

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706

285/25540 Adult Breathing Circuit Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 285/25541 Adult Filtered Breathing Circuit Pressure Monitoring

Line IIa/rule 2 37021/37704/37705/37706

285/25542 Adult Breathing Circuit APL Valve, External Pressure

285/5063Z Adult Breathing Circuit IIa/rule 2 37021/37704/37705/37706

285/7056 Adult Breathing Circuit with Exhalation Valve IIa/rule 2 37021/37704/37705/37706 285/7076 Pediatric Breathing Circuit with Aerosol O2 Mask IIa/rule 2 37021/37704/37705/37706

285/7147 Adult Breathing Circuit with Exhalation Valve IIa/rule 2 37021/37704/37705/37706 285/7177 Adult Breathing Circuit APL Valve IIa/rule 2 37021/37704/37705/37706

(8)

Part Number Rule

285/7227 Adult Breathing Circuit 1-Way Valve IIa/rule 2 37021/37704/37705/37706

285/7345 Adult Breathing Circuit with Exhalation Valve IIa/rule 2 37021/37704/37705/37706 285/7349 Adult Filtered Circuit with Exhalation Valve Pressure

Monitoring Line, Filter HME IIa/rule 2 37021/37704/37705/37706 285/7524 Adult Filtered Circuit with Exhalation Valve Pressure

Pressure Monitoring Line, 1-Way Valve IIa/rule 2 37021/37704/37705/37706

Monitoring Line, Filter HME IIa/rule 2 37021/37704/37705/37706 285/7627 Adult Mapleson E Ayres Circuit T-Piece IIa/rule 2 37021/37704/37705/37706 285/7708 Adult Breathing Circuit with Exhalation Valve

285/7750 Adult Breathing Circuit Mouthpiece IIa/rule 2 37021/37704/37705/37706

285/7833 Adult Breathing Circuit with Exhalation Valve IIa/rule 2 37021/37704/37705/37706 285/7845 Adult Breathing Circuit with Exhalation Valve 1-Way

Valve IIa/rule 2 37021/37704/37705/37706

285/7859 Adult Breathing Circuit 1-Way Valve IIa/rule 2 37021/37704/37705/37706

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 285/7900 Adult Filtered Circuit with Exhalation Valve Pressure

Monitoring Line, Filter HME IIa/rule 2 37021/37704/37705/37706 285/7959 Adult Breathing Circuit with Exhalation Valve

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 285D7744 Adult Breathing Circuit with Exhalation Valve

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 285P25606 Adult Breathing Circuit with Exhalation Valve

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 285P25610Z Adult Breathing Circuit with Exhalation Valve

(9)

285P25777 Adult Breathing Circuit with Filter IIa/rule 2 37021/37704/37705/37706

285P25787 Adult Breathing Circuit IIa/rule 2 37021/37704/37705/37706

285P25803 Adult Breathing Circuit with Exhalation Valve

285S25755 Adult Breathing Circuit IIa/rule 2 37021/37704/37705/37706

285S25760 Adult Breathing Circuit External Pressure Monitoring

Line IIa/rule 2 37021/37704/37705/37706

285S25762 Adult Breathing Circuit Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706

285S5058Z Adult Breathing Circuit IIa/rule 2 37021/37704/37705/37706

285S25574 Adult Breathing Circuit with Aerosol O2 Mask IIa/rule 2 37021/37704/37705/37706 285S25576 Adult Breathing Circuit Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706

285S25631 Adult Breathing Circuit 1-Way Valve IIa/rule 2 37021/37704/37705/37706

285S25646 Adult Breathing Circuit with Filter IIa/rule 2 37021/37704/37705/37706 285S25706 Adult Breathing Circuit Insulated IIa/rule 2 37021/37704/37705/37706

285S25726 Adult Breathing Circuit with Aerosol O2 Mask IIa/rule 2 37021/37704/37705/37706 285S25728 Adult Breathing Circuit with Aerosol O2 Mask IIa/rule 2 37021/37704/37705/37706

285S25750 Adult Breathing Circuit Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 285S25769 Adult Breathing Circuit with Exhalation Valve

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 285S25769Z Adult Breathing Circuit with Exhalation Valve

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 285S25770 Adult Breathing Circuit with Exhalation Valve

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 285S25770Z Adult Breathing Circuit with Exhalation Valve

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 285S25788 Adult Breathing Circuit with Tracheostomy Aerosol

O2 Mask IIa/rule 2 37021/37704/37705/37706

285S25791 Adult Breathing Circuit Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706

(10)

Part Number Rule 285SX0005 Adult Breathing Circuit with Exhalation Valve

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 285SX0035 Adult Breathing Circuit with Exhalation Valve

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 286/25081 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286/25182 Pediatric Breathing Circuit with Anesthesia Mask 1-

Way Valve IIa/rule 2 37021/37704/37705/37706

286/25190 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286/25210 Pediatric Breathing Circuit with Exhalation Valve 1-

286/25222 Infant Breathing Circuit IIa/rule 2 37021/37704/37705/37706

286/25300 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706

286/25377 Pediatric Filtered Circuit with Exhalation Valve For

Puritan Bennett™ Ventilator IIa/rule 2 37021/37704/37705/37706 286/25401 Infant Breathing Circuit Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706

286/25457 Infant Low Compliance Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286/25470 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286/25485 Pediatric Breathing Circuit with Pediatric Aerosol O2

Mask IIa/rule 2 37021/37704/37705/37706

286/25495 Infant Breathing Circuit with Filter IIa/rule 2 37021/37704/37705/37706

286/25551 Pediatric Breathing Circuit with Exhalation Valve

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 286/25554 Pediatric Breathing Circuit Crush Resistant Tubing IIa/rule 2 37021/37704/37705/37706 286/5065 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286/5066 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286/5067 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286/5068 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286/5069 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286/5070 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286/5071 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286/7040 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286/7071 Infant Breathing Circuit with Pediatric Aerosol O2

Mask IIa/rule 2 37021/37704/37705/37706

286/7095 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286/7250 Infant Mapleson F Circuit Jackson Rees IIa/rule 2 37021/37704/37705/37706 286/7252 Infant Mapleson F Circuit Jackson Rees IIa/rule 2 37021/37704/37705/37706 286/7274 Infant Breathing Circuit with Exhalation Valve

Monitoring Line Filter, 1-Way Valve IIa/rule 2 37021/37704/37705/37706 286/7276 Pediatric Mapleson F Circuit Jackson Rees IIa/rule 2 37021/37704/37705/37706 286/7308 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286/7356 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706

(11)

286/7438 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286/7447 Adult Breathing Circuit with Exhalation Valve IIa/rule 2 37021/37704/37705/37706 286/7465 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286/7481 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286/7486 Pediatric Breathing Circuit with Pediatric Aerosol O2

Mask IIa/rule 2 37021/37704/37705/37706

286/7487 Infant Breathing Circuit with Pediatric Aerosol O2

Mask IIa/rule 2 37021/37704/37705/37706

286/7539 Pediatric Breathing Circuit with Exhalation Valve

286/7660 Infant Mapleson D Circuit APL Valve IIa/rule 2 37021/37704/37705/37706 286/7669 Infant Mapleson E Ayres Circuit T-Piece IIa/rule 2 37021/37704/37705/37706 286/7677 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286/7691 Infant Breathing Circuit Mouthpiece IIa/rule 2 37021/37704/37705/37706 286/7723 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286/7768 Infant Breathing Circuit with Pediatric Aerosol O2

Mask IIa/rule 2 37021/37704/37705/37706

286/7777 Infant Mapleson E Ayres Circuit T-Piece IIa/rule 2 37021/37704/37705/37706 286/7780 Adult Breathing Circuit with Aerosol O2 Mask IIa/rule 2 37021/37704/37705/37706

286/7814 Infant Mapleson F Circuit Jackson Rees IIa/rule 2 37021/37704/37705/37706 286/7829 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286/7836 Pediatric Breathing Circuit with Exhalation Valve

286/7922 Infant Breathing Circuit with Filter IIa/rule 2 37021/37704/37705/37706

286P25355 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706

286P25532 Infant Breathing Circuit IIa/rule 2 37021/37704/37705/37706

286P25749 Infant Breathing Circuit with Anesthesia Mask IIa/rule 2 37021/37704/37705/37706 286P25800 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286P25802 Pediatric Breathing Circuit with Exhalation Valve

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 286R25691 Infant Mapleson F Circuit Jackson Rees, Multiple

Patient Use IIa/rule 2 37021/37704/37705/37706

286R25692 Infant Mapleson D Circuit APL Valve, Multiple Patient

Use IIa/rule 2 37021/37704/37705/37706

286S25643 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286S25654 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286S25705 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 286S25720 Infant Breathing Circuit with Connector Set Pressure

286S25721 Pediatric Breathing Circuit 1-Way Valve IIa/rule 2 37021/37704/37705/37706 286S25738 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 286S25757 Pediatric Breathing Circuit Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 286S25766 Infant Breathing Circuit Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706

286S25785 Infant Breathing Circuit IIa/rule 2 37021/37704/37705/37706

286S25796 Pediatric Breathing Circuit with Anesthesia Mask 1-

(12)

Part Number Rule 286SX25775 Pediatric Breathing Circuit with Exhalation Valve

290/25179 Adult Breathing Circuit with Anesthesia Mask 1-Way

Valve IIa/rule 2 37021/37704/37705/37706

290/25241 Adult Breathing Circuit with Tent Mask IIa/rule 2 37021/37704/37705/37706 290/25246 Adult Breathing Circuit with Anesthesia Mask IIa/rule 2 37021/37704/37705/37706

290/25443 Adult Breathing Circuit with Exhalation Valve IIa/rule 2 37021/37704/37705/37706

290/25501 Adult Breathing Circuit with Venturi Set IIa/rule 2 37021/37704/37705/37706

290/5035 Adult Tubing Roll IIa/rule 2 37021/37704/37705/37706

290/7058 Adult Breathing Circuit with Tent Mask IIa/rule 2 37021/37704/37705/37706

290/7598 Adult Breathing Circuit with Tent Mask IIa/rule 2 37021/37704/37705/37706 290P25352 Adult Breathing Circuit 1-Way Valve IIa/rule 2 37021/37704/37705/37706 290P25780 Adult Breathing Circuit with Exhalation Valve IIa/rule 2 37021/37704/37705/37706

290S25617 Adult Breathing Circuit with Exhalation Valve IIa/rule 2 37021/37704/37705/37706 300/13074 Adult Breathing Circuit with Venturi Set 1-Way Valve IIa/rule 2 37021/37704/37705/37706

300/13488 Adult Breathing Circuit with Venturi Set 1-Way Valve IIa/rule 2 37021/37704/37705/37706

300/13957 Adult Breathing Circuit Insulated IIa/rule 2 37021/37704/37705/37706 300/14031 Adult Breathing Circuit with Filter HME IIa/rule 2 37021/37704/37705/37706 300/14032 Adult Breathing Circuit with Filter HME IIa/rule 2 37021/37704/37705/37706 300/14086 Adult Breathing Circuit with Filter IIa/rule 2 37021/37704/37705/37706

(13)

300/6253 Adult Breathing Circuit Reusable IIa/rule 2 37021/37704/37705/37706

300/6367 Nebulizer Set with Filter 1-Way Valve IIa/rule 2 37021/37704/37705/37706

300/6644 Adult Breathing Circuit with Filter HME IIa/rule 2 37021/37704/37705/37706

300/6668 Adult Breathing Circuit with Filter HME IIa/rule 2 37021/37704/37705/37706

300NP14344 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 300NP14345 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 300NP14346 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 300NP14347 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 300NP14348 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 300NP14349 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 300NP14366 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 301NP14330 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 301NP14331 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 301NP14332 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 301NP14333 Adult Breathing Circuit with Filter Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 301NP14334 Adult Breathing Circuit with Filter Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 301NP14335 Adult Breathing Circuit with Filter Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 301NP14336 Adult Breathing Circuit with Filter Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 301NP14337 Adult Breathing Circuit with Filter Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 301NP14338 Adult Breathing Circuit with Filter Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 300NP14370 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 300NP14371 Adult Breathing Circuit with Filter Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 300NP14375 Adult Breathing Circuit with Filter Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 300NP14382 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706

300P13849 Adult Breathing Circuit with Aerosol O2 Mask

Reservoir IIa/rule 2 37021/37704/37705/37706

300P14147Z Adult Breathing Circuit IIa/rule 2 37021/37704/37705/37706

300P14340 Adult Breathing Circuit with Aerosol O2 Mask

(14)

Part Number Rule 300P14342 Adult Breathing Circuit with Aerosol O2 Mask

300P14426 PE Adult Breathing Circuit IIa/rule 2 37021/37704/37705/37706 300P16000 Adult Anesthesia Extendible circuit/3 L. Breath.bag IIa/rule 2 37021/37704/37705/37706 300P16001 Ext Adult Breathing Circuit w 2 lt bag IIa/rule 2 37021/37704/37705/37706

300P16002 Ext. Breathing Circuit IIa/rule 2 37021/37704/37705/37706

300R14279 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 300R14281 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 300R14317 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 300R14318 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 300R14319 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 300R14414 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 300R14421 Adult Breathing Circuit with Swivel Wye Multiple

Patient Use, 2 L 200 cm IIa/rule 2 37021/37704/37705/37706

300R14422 Adult Breathing Circuit with Swivel Wye Multiple

Patient Use, 2 L 300 cm IIa/rule 2 37021/37704/37705/37706

300R14428 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706

300S14353 Adult Breathing Circuit APL Valve IIa/rule 2 37021/37704/37705/37706

300S14425 Adult Breathing system, 2L Breathing Bag IIa/rule 2 37021/37704/37705/37706

301/13425 Adult Breathing Circuit Nebulizer IIa/rule 2 37021/37704/37705/37706

301/14008 Adult Breathing Circuit Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706

301/14133 Adult Breathing Circuit with Filter IIa/rule 2 37021/37704/37705/37706 301/6119 Adult Filtered Breathing Circuit Pressure Monitoring

Line IIa/rule 2 37021/37704/37705/37706

(15)

301/6398 Adult Breathing Circuit Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 301/6475 Adult Filtered Breathing Circuit Pressure Monitoring

Line IIa/rule 2 37021/37704/37705/37706

301/6476 Adult Filtered Breathing Circuit Pressure Monitoring

Line IIa/rule 2 37021/37704/37705/37706

301/6659 Adult Breathing Circuit Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 301NP14321 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 301NP14322 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 301NP14323 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 301NP14324 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 301NP14325 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 301NP14326 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 301NP14327 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 301NP14328 Adult Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 301P14381 Adult Breathing Circuit Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 301S13352Z Adult Breathing Circuit with Exhalation Valve

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 301S13425Z Adult Breathing Circuit Nebulizer IIa/rule 2 37021/37704/37705/37706 301S14110 Adult Breathing Circuit Nebulizer IIa/rule 2 37021/37704/37705/37706 301S14110Z Adult Breathing Circuit Nebulizer IIa/rule 2 37021/37704/37705/37706

301S14316 Adult Breathing Circuit Insulated IIa/rule 2 37021/37704/37705/37706 301S14389 Adult Breathing Circuit with Filter HME IIa/rule 2 37021/37704/37705/37706 301S14390 Adult Breathing Circuit with Filter HME IIa/rule 2 37021/37704/37705/37706

301S14401 Adult Breathing Circuit with Filter HME IIa/rule 2 37021/37704/37705/37706 301S14401Z Adult Breathing Circuit with Filter HME IIa/rule 2 37021/37704/37705/37706 302S14192 Adult Breathing Circuit with Filter IIa/rule 2 37021/37704/37705/37706 302S14310 Adult Breathing Circuit with Filter HME IIa/rule 2 37021/37704/37705/37706 303/13290 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 303/13322 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303/13609 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303/13976 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303/13977 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303/14012 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303/14070 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303/14095 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303/14127 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303/5140 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 303/6012 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303/6013 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 303/6057 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 303/6062 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303/6068 Adult Breathing Circuit Water Trap, 2 L Breathing

Bag IIa/rule 2 37021/37704/37705/37706

303/6086 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706

(16)

303/6090 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303/6112 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303/6117 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303/6124 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303/6141 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303/6168 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303/6173 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 303/6243 Adult Breathing Circuit Insulated, Water Trap, 2 L

Breathing Bag IIa/rule 2 37021/37704/37705/37706

303/6296 Adult Breathing Circuit Water Trap, 2 L Breathing

Bag IIa/rule 2 37021/37704/37705/37706

303/6298 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303/6334 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 303/6344 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 303/6376 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303/6397 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 303/6506 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303/6521 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303/6594 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303NP14419 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303NP14420 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303P13534 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303P14360 Adult Breathing Circuit Water Trap, 2 L Breathing

Bag IIa/rule 2 37021/37704/37705/37706

303S14127Z Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303S14095Z Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303S14238 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303S14352 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303S14386 Adult Breathing Circuit Water Trap, 2 L Breathing

Bag IIa/rule 2 37021/37704/37705/37706

303S14410 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 303S14424 Adult Breathing Circuit Water Trap, 2L Breathing Bag IIa/rule 2 37021/37704/37705/37706 304/13100 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/13212 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/13284 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/13320 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/13353 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/13482 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/13507 Adult Breathing Circuit Filtered Pressure Monitoring

Line IIa/rule 2 37021/37704/37705/37706

304/13563 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/13565 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/13567 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/13576 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/13597 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/13607 Adult Breathing Circuit Water Trap, 3 L Breathing

Bag IIa/rule 2 37021/37704/37705/37706

304/13614 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/13624 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/13674 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/13686 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/13693 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/13768 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/13798 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706

(17)

304/13859 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/13874 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/13972 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/14004 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/14007 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/14034 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/14064 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/14066 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/14087 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/14094 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/14101 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/14108 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/14143 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/6023 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/6061 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/6085 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/6085Z Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/6089 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/6116 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/6121 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/6126 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/6210 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/6239 Adult Breathing Circuit Insulated, Water Trap, 2 L

Breathing Bag IIa/rule 2 37021/37704/37705/37706

304/6297 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/6400 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/6404 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/6486 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/6510 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/6518 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/6579 Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304/6648 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304/6652 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304P14234 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304P14234Z Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304S13859Z Adult Breathing Circuit Insulated, Water Trap IIa/rule 2 37021/37704/37705/37706 304S14094Z Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304S14101Z Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304S14143Z Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304S14177 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304S14365 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304S14368 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304S14378 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304S14394 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 304S14409 Adult Breathing Circuit with Exhalation Valve Water

Trap IIa/rule 2 37021/37704/37705/37706

305/6712 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 305/6713 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 305/6714 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 305/6722 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 305/6745 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 305/6748 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 305/6754 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706

(18)

305/6783 Infant Breathing Circuit with Exhalation Valve

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 305/6784 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 305/6806 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 305/6828 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 305/6841 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706

305/6891 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 305/6907 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 305/6967 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706

305/8174 Infant Circuit with Exhalation Valve Filtered Pressure

Monitoring Line, Tube Holders IIa/rule 2 37021/37704/37705/37706

305/8213 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 305/8229 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 305/8247 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706

305/8279 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 305/8298 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 305/8300 Infant Breathing Circuit with Exhalation Valve

Monitoring Line, Filter IIa/rule 2 37021/37704/37705/37706

Monitoring Line, Filter and Tube Holders IIa/rule 2 37021/37704/37705/37706 305/8552 Infant Breathing Circuit with Exhalation Valve

305/8705 Infant Breathing Circuit with Filter HME IIa/rule 2 37021/37704/37705/37706 305/8707 Pediatric Breathing Circuit with Filter HME IIa/rule 2 37021/37704/37705/37706 305/8759 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 305/8773 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 305/8800 Infant Circuit with Exhalation Valve Filtered Pressure

Monitoring Line, Filter HME IIa/rule 2 37021/37704/37705/37706 305/8804 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706

(19)

305G8926 Pediatric Breathing Circuit with Breathing Bag IIa/rule 2 37021/37704/37705/37706

305P8803 Infant Breathing Circuit IIa/rule 2 37021/37704/37705/37706

305P8856 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 305P9903 Infant Breathing Circuit Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 305P9936 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 305R8954 Pediatric Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 305R8955 Pediatric Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 305R8956 Pediatric Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 305R9909 Pediatric Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706 305R9941 Pediatric Breathing Circuit Multiple Patient Use IIa/rule 2 37021/37704/37705/37706

305S8903 Pediatric Breathing Circuit with Filter IIa/rule 2 37021/37704/37705/37706 305S8908 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 305S8922 Infant Breathing Circuit with Filter IIa/rule 2 37021/37704/37705/37706

305S8935 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706

305S8976 Infant Breathing Circuit with Exhalation Valve IIa/rule 2 37021/37704/37705/37706 305S8978 Infant Breathing Circuit Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706

305S8983 Infant Breathing Circuit Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 305S8984 Pediatric Breathing Circuit APL Valve IIa/rule 2 37021/37704/37705/37706 305S9913 Pediatric Breathing Circuit with Filter HME IIa/rule 2 37021/37704/37705/37706 305S9920 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706

305S9934 Infant Breathing Circuit Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 306/6705 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 306/6711 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 306/6716 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 306/6718 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 306/6741 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 306/6890 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 306/6899 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 306/6904 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 306/6948 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 306/6976 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 306/8095 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 306/8099 Pediatric Breathing Circuit with Filter HME IIa/rule 2 37021/37704/37705/37706 306/8217 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 306/8221 Pediatric Breathing Circuit with Filter IIa/rule 2 37021/37704/37705/37706 306/8517 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 306/8562 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 306/8683 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 306/8706 Pediatric Breathing Circuit with Filter HME IIa/rule 2 37021/37704/37705/37706 306/8723 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 306/8754 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 306/8787 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 306/8815 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 306G8925 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 306S8855 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706

(20)

306S8901 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 306S8909 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 306S9901 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/6747 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/6773 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/6804 Pediatric Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/6819 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/6894 Infant Filtered Breathing Circuit IIa/rule 2 37021/37704/37705/37706 307/6920 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/6922 Infant Low Compliance Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/6965 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/6981 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/6990 Infant Low Compliance Breathing Circuit IIa/rule 2 37021/37704/37705/37706 307/8042 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/8094 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/8127 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/8231 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/8311 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/8440 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/8441 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/8445 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/8448 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/8470 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/8587 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/8604 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/8626 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307/8786 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307P8991 Infant Breathing Circuit Water Trap, 1 L Breathing

Bag IIa/rule 2 37021/37704/37705/37706

307S8957 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 307S8988 Infant Breathing Circuit with Exhalation Valve

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 307S9932 Infant Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706

308/6075 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 308/6094 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706

308/6270 Adult Breathing Circuit Water Trap IIa/rule 2 37021/37704/37705/37706 308/8223 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706 308S14362 Adult Breathing Circuit Internal Pressure Monitoring

Line IIa/rule 2 37021/37704/37705/37706

5093100 Pediatric Breathing Circuit IIa/rule 2 37021/37704/37705/37706

5093300 Adult Breathing Circuit IIa/rule 2 37021/37704/37705/37706

5093300Z Adult Breathing Circuit Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 5093301 Adult Breathing Circuit Internal Pressure Monitoring

Line IIa/rule 2 37021/37704/37705/37706

5093500 Pediatric Breathing Circuit with Exhalation Valve IIa/rule 2 37021/37704/37705/37706

(21)

5093501 Pediatric Breathing Circuit with Exhalation Valve IIa/rule 2 37021/37704/37705/37706 5093600 Adult Breathing Circuit with Exhalation Valve IIa/rule 2 37021/37704/37705/37706 5093601 Adult Breathing Circuit with Exhalation Valve IIa/rule 2 37021/37704/37705/37706 5093900 Pediatric Breathing Circuit with Exhalation Valve

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 5093900Z Pediatric Breathing Circuit with Exhalation Valve

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 5093901 Pediatric Breathing Circuit with Exhalation Valve

Pressure Monitoring Line Water Traps IIa/rule 2 37021/37704/37705/37706 5094000 Adult Breathing Circuit with Exhalation Valve

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 5094000Z Adult Breathing Circuit with Exhalation Valve

Pressure Monitoring Line IIa/rule 2 37021/37704/37705/37706 5094001 Adult Breathing Circuit with Exhalation Valve

Pressure Monitoring Line Water Traps IIa/rule 2 37021/37704/37705/37706

Medical Device

Part Number Description Class/

Rule GMDN Code and TerM Catheters

DAR3305321 Catheter Mount IIa/rule 2 42476

DAR3305322 Catheter Mount IIa/rule 2 42476

330/5109 Catheter Mount IIa/rule 2 42476

330/5321 Catheter Mount CO2 Sampling Port IIa/rule 2 42476 330/5321TC Catheter Mount CO2 Sampling Port, Tethered Cap IIa/rule 2 42476 330/5322 Catheter Mount CO2 Sampling Port IIa/rule 2 42476

330/5337 Catheter Mount Extendable IIa/rule 2 42476

330/5645 Catheter Mount CO2 Sampling Port IIa/rule 2 42476 330/5646 Catheter Mount CO2 Sampling Port IIa/rule 2 42476 330/5646TC Catheter Mount CO2 Sampling Port, Tethered Cap IIa/rule 2 42476 330/5664 Catheter Mount Extendable, CO2 Sampling Port IIa/rule 2 42476 330/5667 Catheter Mount Extendable, CO2 Sampling Port IIa/rule 2 42476 330/5667TC Catheter Mount Extendable, CO2 Sampling Port,

Tethered Cap IIa/rule 2 42476

330/5678 Catheter Mount Extendable IIa/rule 2 42476

331/5313 Carlens Catheter Mount For Endobronchial Tube IIa/rule 2 42476