imuflex wb-sp blood bag system with integral whole blood leukocyte reduction filter (saving platelets) with diversion blood sampling arm
IMUFLEX WB-SP BLOOD BAG SYSTEM with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm
Approved
Approval ID
4d08424e-1ae1-41a4-b50b-e4ce4b828bdd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2021
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 (CPD)
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53877-010
Application NumberBN880217
Product Classification
M
Marketing Category
C73594
G
Generic Name
Anticoagulant Citrate Phosphate Dextrose (CPD)
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 10, 2021
FDA Product Classification
INGREDIENTS (5)
Anhydrous Citric AcidActive
Quantity: 209 mg in 70 mL
Code: XF417D3PSL
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Dextrose MonohydrateActive
Quantity: 1.79 g in 70 mL
Code: LX22YL083G
Classification: ACTIB
Sodium Phosphate, Monobasic, Unspecified FormActive
Quantity: 156 mg in 70 mL
Code: 3980JIH2SW
Classification: ACTIB
Trisodium Citrate DihydrateActive
Quantity: 1.84 g in 70 mL
Code: B22547B95K
Classification: ACTIM