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Pall Sterile Cord Blood Collection Unit

Sterile Cord Blood Collection Unit

Approved
Approval ID

a72d2782-96cc-2a9d-e053-2995a90afc08

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 3, 2020

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.

Sterile Cord Blood Collection Unit

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53157-791
Application NumberBN800222
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sterile Cord Blood Collection Unit
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 3, 2020
FDA Product Classification

INGREDIENTS (6)

CITRIC ACID MONOHYDRATEActive
Quantity: 0.114 g in 35 mL
Code: 2968PHW8QP
Classification: ACTIM
SODIUM CITRATEActive
Quantity: 0.921 g in 35 mL
Code: 1Q73Q2JULR
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEActive
Quantity: 0.0078 g in 35 mL
Code: 593YOG76RN
Classification: ACTIB
DEXTROSE MONOHYDRATEActive
Quantity: 0.893 g in 35 mL
Code: LX22YL083G
Classification: ACTIB
WATERInactive
Quantity: 35 g in 35 mL
Code: 059QF0KO0R
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT

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Pall Sterile Cord Blood Collection Unit - FDA Drug Approval Details