Quadruple Blood bag with SAGM for whole blood collection and separation of 3 different blood components red blood cell, plasma and platelets through the buffy coat method. The primary bag contains CPD solution and has 3 satellite bags. One Satellite bag is of 100ml capacity to prepare platelets through the buffy coat method. One satellite bag is valid for 5 days of platelet storage..
Other Specifications Download Specification | |
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Conformity To Indian Standard | IS:9824(Part-3) Latest |
ISI Marked | No |
CM/L No | 00 |
Type Of IV Set | Transfusion Set for Single Use (Designation : Transfusion Set IS 9824-3 TS) |
Transfusion/Infusion Set Provided With Injection Site | Yes |
Provision Of Closure Of Air Inlet With Vented Infusion Set | Yes |
Air Inlet Device With Air Filter Required | Yes |
Luer Lock Fitting | Yes |
I V Set Comply With The Provisions Of Drugs And Cosmatic Act 1940 As Amended Till Date | Yes |
Good Manufacturing Practices (GMP) Issued Under Revised Schedule -M Of Drugs And Cosmetics Act 1940 As Amended Or WHO-Good Manufacturing Practices (GMP)(For Manufacturers Only) | Yes |
Good Manufacturing Practices (GMP) Certificate No. | ML2-10461/2016/DC |
Good Manufacturing Practices (GMP) Certificate Date | 23/11/2016 |
Non Conviction Certificate Issued By The Concerned Drugs Control Authorities/ Licencing Authorities | Yes |
Non Conviction Certificate No. | ML2-7735/2017/DC |
Non Conviction Certificate Date | 05/07/2017 |
Availability Of Test Reports From Drug Controller Approved Laboratories Which Are Also Satisfying Central Govt./State Govt/NABL/IL AC Accredited Lab Covering All The Declared Parameters As Per IS Specification | Yes |
Test Report No | FR-QCD-73/A |
Test Report Date | 20-07-2017 |
Name Of The Lab | QC laboratory blood bag factory Terumo Penpol |
Address Of The Lab | Thiruvananthapuram |