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FDA Product

TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)

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

Basic Information

TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)

53877-001

Regulatory Information

53877-001

BN820528

C73594

December 7, 2018

USA

TERUFLEX BLOOD BAG SYSTEM with Blood Sampling Arm

HUMAN PRESCRIPTION DRUG LABEL

5

Company Information

Terumo Corporation

690543319

Active Ingredients

Adenine

Quantity: 0.275 g in 1000 mL

Code: JAC85A2161

Class Code: ACTIB

Anhydrous Citric Acid

Quantity: 2.99 g in 1000 mL

Code: XF417D3PSL

Class Code: ACTIB

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Quantity: 2.22 g in 1000 mL

Code: 593YOG76RN

Class Code: ACTIB

Dextrose Monohydrate

Quantity: 31.9 g in 1000 mL

Code: LX22YL083G

Class Code: ACTIB

Water

Code: 059QF0KO0R

Class Code: IACT

Trisodium Citrate Dihydrate

Quantity: 26.3 g in 1000 mL

Code: B22547B95K

Class Code: ACTIM

Active Moieties

Anhydrous Citric Acid

Code: XF417D3PSL

PHOSPHATE ION

Code: NK08V8K8HR

Adenine

Code: JAC85A2161

Anhydrous Dextrose

Code: 5SL0G7R0OK

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