Application Nr Approved Date Route Status External Links
BN000127 None Extracorporeal None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

I. Indications For Use The Haemonetics 250ml Anticoagulant Citrate Phosphate Double Dextrose (cp2d) And 250ml Additive Solution Formula 3 (as-3) Nutrient Solution Are Intended To Be Used Only With Automated Apheresis Devices For Collecting Human Blood And Blood Components. The Anticoagulant Solution Is Metered By The Apheresis Machine Into The Collected Whole Blood. It Is Not To Be Infused Directly Into The Donor. After The Anticoagulant Is Used, The Bag In Which It Was Contained Is Discarded. When Collecting Plasma In The Rbcp Protocol, The Plasma Is Collected Into An Empty Plasma Collection Bag. One Hundred Milliliters (100ml) Of As-3 Is Transferred Into One Rbc Collection Bag When Using The Rbcp Protocol Or 2 Separate Bags When Using The 2rbc Protocol. As-3 Solution Provides Nutrients To Keep The Red Blood Cells Viable For 42 Days When Refrigerated. Cp2d Is Also Indicated For The Collection Of Ffp And Pf24 Plasma, Collected And Stored Plasma Collected Using The 822, 822-2p And 822f-2p Disposable Sets May Be Frozen Within 8 Hours (ffp) Or Within 24 Hours Which Includes 8 Hours Room Temperature Storage And 16 Hours Refrigeration Storage (pf24). The 300ml As-3 Is Used In Conjunction With Automated Red Blood Cell Washing Devices. As-3 Serves As The Nutrient Solution For Storage Of The Red Blood Cell Product After Deglycerolization. The Red Blood Cells Are Washed Using The Model 215 System. As-3 Is Used For Priming The Disposable And For The Last Wash Of The Red Blood Cells. The Washed Cells Are Then Re-Suspended In 100ml Of The As-3 Before Transfer Into A Product Collection Bag Or Storage Bag. Additive Solution Formula 3 (as-3) Provides Nutrients To Keep The Washed Red Blood Cells Viable For Up To 14 Days After Washing When Refrigerated. Neither The Cp2d Nor The As-3 Container Is Used For The Storage Of Blood Or Blood Components.

All Formulated Excipients (0 Total)

None

Comments