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Leukotrap WB System

Leukotrap WB System, CPDA-1 Blood Collection Set with WBF2 Filter and Sampling System

Approved
Approval ID

b2064cb0-542d-41d4-82ef-e7e6a53b9400

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 19, 2023

Manufacturers
FDA

Haemonetics Corporation

DUNS: 057827420

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

CPDA-1 Blood Bag Collection System

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53157-736
Application NumberBN800077
Product Classification
M
Marketing Category
C73594
G
Generic Name
CPDA-1 Blood Bag Collection System
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 19, 2023
FDA Product Classification

INGREDIENTS (5)

DEXTROSE MONOHYDRATEActive
Quantity: 2.01 g in 63 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM CITRATEActive
Quantity: 1.66 g in 63 mL
Code: 1Q73Q2JULR
Classification: ACTIB
CITRIC ACID MONOHYDRATEActive
Quantity: 0.206 g in 63 mL
Code: 2968PHW8QP
Classification: ACTIM
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEActive
Quantity: 0.14 g in 63 mL
Code: 593YOG76RN
Classification: ACTIB
ADENINEActive
Quantity: 0.017 g in 63 mL
Code: JAC85A2161
Classification: ACTIB

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Leukotrap WB System - FDA Drug Approval Details