TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)
TERUFLEX® BLOOD BAG SYSTEMCPDA-1 SOLUTION
Approved
Approval ID
991fb1d2-eb44-4ab7-904e-79476b2190f0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2018
Manufacturers
FDA
Terumo Corporation
DUNS: 690543319
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53877-001
Application NumberBN820528
Product Classification
M
Marketing Category
C73594
G
Generic Name
Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 6, 2018
FDA Product Classification
INGREDIENTS (6)
Anhydrous Citric AcidActive
Quantity: 2.99 g in 1000 mL
Code: XF417D3PSL
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEActive
Quantity: 2.22 g in 1000 mL
Code: 593YOG76RN
Classification: ACTIB
Dextrose MonohydrateActive
Quantity: 31.9 g in 1000 mL
Code: LX22YL083G
Classification: ACTIB
AdenineActive
Quantity: 0.275 g in 1000 mL
Code: JAC85A2161
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Trisodium Citrate DihydrateActive
Quantity: 26.3 g in 1000 mL
Code: B22547B95K
Classification: ACTIM