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IMUFLEX WB-RP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Removing Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative

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

Approved
Approval ID

8b22a4c8-2d6e-45d5-82e2-02ef0b713095

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 18, 2019

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) AND AS-5 Red Cell Preservative

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53877-006
Application NumberBN880217
Product Classification
M
Marketing Category
C73594
G
Generic Name
Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 18, 2019
FDA Product Classification

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IMUFLEX WB-RP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Removing Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative - FDA Drug Approval Details