PALL STERILE CORD BLOOD COLLECTION UNIT- sterile cord blood collection unit solution

Pall Sterile Cord Blood Collection Unit by

Drug Labeling and Warnings

Pall Sterile Cord Blood Collection Unit by is a Prescription medication manufactured, distributed, or labeled by Pall Corporation, Haemonetics Manufacturing Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

Making multiple punctures of the umbilical cord to increase collection volume may increase the risk of contamination.

Do not irradiate collected cord blood or components.

HOW SUPPLIED

The Collection Unit inside the overwrap pouch, within the foil envelope, are sterile and acceptable for use in a sterile field if pouch is unopened and undamaged.

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION (CPD)

Sterile, non-pyrogenic fluid path. Sterilized by steam.

This product is free of natural rubber latex.

Indications and Usage Section

For collection of up to 210 ml of umbilical cord blood. Use aseptic technique.

Contents inside overwrap pouch, within the foil envelope, are sterile and acceptable for use in a sterile field if pouch is unopened and undamaged; visual inspection to confirm the integrity of overwrap pouch should be performed.

GENERAL PRECAUTIONS

Do not use if the package is damaged or seal is incomplete. Use only if solution is clear.
Sealing should be done in a manner that avoids fluid splatter.

Always dispose of blood-contaminated products in a manner consistent with established BIOHAZARD safety procedures.

INFORMATION FOR PATIENTS

For customer service, call: 1.800.645.6578

DonorCare is a registered trademark of ITL Corporation, Canberra, Australia. Produced under license from ThermoGenesis Corp

1. Ensure DonorCare® Needle Guard (DCNG) is positioned on the tubing between the needle hub and Pinch Clamp. Engage Pinch Clamp. Ensure tethered cap is placed securely on the air vent.
2. Using aseptic technique, insert needle into umbilical vein, disengage Pinch Clamp to collect cord blood, mixing frequently, according to standard procedures.
3. Upon completion of collection, engage Pinch Clamp then withdraw needle from umbilical vein. Slide the DCNG midway over the needle hub. While holding the sides of DCNG near front, grasp tubing and pull smoothly, pulling needle into the DCNG until it locks into place. Confirm that needle is locked by listening for the second click as the needle is drawn into the DCNG. Ensure that tubing cannot be pulled through DCNG.
4. Place the bag on a work surface. While holding the tubing above the bag, open the tethered cap on the air vent. Allow the blood to drain from the tubing into the bag.
5. When the tubing has been drained, hold tubing vertical and seal tubing directly below the Y-piece with air vent.
6. Detach and discard needle, DCNG, Pinch Clamp, Air Vent and tubing according to standard procedures.
7. Determine amount of anticoagulated blood collected. If required, add sedimenting agent to CPD anticoagulated blood through Sample Port using a syringe according to standard procedures.
8. Mix well. Take care to strip and mix any blood in tubing.
9. Load bag into centrifuge cup. It is suggested that a means of support is used to prevent bag from collapsing and to reduce wrinkles.
10. Centrifuge according to standard procedures to obtain mononuclear cell-rich plasma.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PALL STERILE CORD BLOOD COLLECTION UNIT 
sterile cord blood collection unit solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 79403-791
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CITRATE (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	SODIUM CITRATE	0.921 g  in 35 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	0.114 g  in 35 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	0.0078 g  in 35 mL
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	0.893 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	35 g  in 35 mL
PHOSPHORIC ACID (UNII: E4GA8884NN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79403-791-08	35 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	BN800222	12/18/2025

Labeler - Global Life Sciences Solutions USA LLC (011658242)

Registrant - GVS TM INC (119067149)

Establishment
Name	Address	ID/FEI	Business Operations
GVS TM, INC		119067149	manufacture(79403-791)