CODE: SC-450SD Version: 01
1/2 JIAXING TIANHE PHARMACEUTICAL CO., LTD.
CPDA-1 Single Blood Bag with 16G Needle, 450ml
REF. SC-450SD
I.1 Registration Number
China CE0197
I.2 CE Scope: Blood Bag I.3 Barcode Type: Code 128 ISBT I.4 Language on labels: English
Solution Type Nominal Qty Final Limits Collected Volume Others
N·(2) CPDA-1 63ml 63-66ml 450ml R3800
Length (±5%) Inner Diameter
N·(3) 950mm 0.30cm
N·(4) 275mm 0.30cm
N·(5) 200mm 0.30cm
Specifications
N·(6) Outlet ports and peel-off ports covers N·(7) Slits and Holes
N·(8) Needle Guard N·(9) Snap-to-open tip Product Description
I. Registration Regulations:
II. Bag Characteristics:
III. Tubing Characteristics (after sterilization):
IV. Fittings
CODE: SC-450SD Version: 01
2/2 JIAXING TIANHE PHARMACEUTICAL CO., LTD.
N·(10) Vacuum Tube Holder N·(11) Sampling Device
N·(1): 16G blood collection needle with needle cover
VII.1 Individual Package: PET vacuum bag VII.2 Outer Package: Aluminum foil bag Qty per aluminum foil: 5 blood bags VII.3 Shipping Package: Carton
Qty per carton: 100 blood bags (20 aluminum foil bags) VII.4 Expiry Date:
Closed aluminum foil bag: 3years Opened aluminum foil bag: 15days Opened individual Package: 72hours VII.5 Recommended storage conditions:
Preserve in well-closed container protected from light and store in a cool place.
Unused Bag stored at Temperature less than 30℃, relative humidity less than 90%.
Bag containing whole blood stored at 2-6℃.
VII.6 Batch Number Configuration:
Year (2 figures)-Months (2 figures)-Day (2 figures)
Example: 100118 means produced and sterilized on January 18th 2010.
VII.7 Note: Statements contained in this document are for reference only. For contractual information please refer to products labels.
Tests are performed in accordance with internal standards and requirements of USP36-NF31, ISO 10993-1, ISO 3826-1:2013, ISO 3826-3:2006 etc., and are listed as below:
VIII.1 Needle: bevel, diameter, length, needle point, silicon coating, blue dot/line on bevel side, sharpness penetration test, pull test, air leak test, re-capping test
VIII.2 Bag: integrity test, product configuration, dimension test, air content, pressure test, rate of collection, suspension test, thermal stability, water vapor transmission, resistance to centrifugation, particulate contamination, solution volume, Residue on ignition of PVC film
VIII.3 Labelling: labeling adherence, temper proof, printing quality, text conformity VIII.4 Bacterial endotoxin. Pyrogen
VIII.5 Sterility
VIII.6 Solutions (CPDA-1)
Total phosphate, sodium, dextrose, adenine, total citrate, PH, chloride, clarity& impurity, particulate matter, UV-abs
ISO 13485:2012, ISO 9001:2008 V. Needle:16G
VI. Sterilization: Steam VII. Packaging:
VIII. Test performed on product :
IX. General Manufacturing Procedure in compliance with :
