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FDA Product

imuflex wb-sp blood bag system with integral whole blood leukocyte reduction filter (saving platelets) with diversion blood sampling arm

Product approved by U.S. Food and Drug Administration (US)

Basic Information

imuflex wb-sp blood bag system with integral whole blood leukocyte reduction filter (saving platelets) with diversion blood sampling arm

53877-010

Regulatory Information

53877-010

BN880217

C73594

December 10, 2021

USA

IMUFLEX WB-SP BLOOD BAG SYSTEM with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

Terumo Corporation

690543319

Active Ingredients

Anhydrous Citric Acid

Quantity: 209 mg in 70 mL

Code: XF417D3PSL

Class Code: ACTIB

Water

Code: 059QF0KO0R

Class Code: IACT

Dextrose Monohydrate

Quantity: 1.79 g in 70 mL

Code: LX22YL083G

Class Code: ACTIB

Sodium Phosphate, Monobasic, Unspecified Form

Quantity: 156 mg in 70 mL

Code: 3980JIH2SW

Class Code: ACTIB

Trisodium Citrate Dihydrate

Quantity: 1.84 g in 70 mL

Code: B22547B95K

Class Code: ACTIM

Active Moieties

Anhydrous Dextrose

Code: 5SL0G7R0OK

Anhydrous Citric Acid

Code: XF417D3PSL

Sodium Cation

Code: LYR4M0NH37

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