PALL STERILE CORD BLOOD COLLECTION UNIT- sterile cord blood collection unit solution 
Global Life Sciences Solutions USA LLC

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Sterile Cord Blood Collection Unit

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.

Warnings Section

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.

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.

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.

INFORMATION FOR PATIENTS

Visit us at www.pall.com/medical

For Pall 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.

Printed Pouch LabelIFU_FRIFUCase labelBag label

PALL STERILE CORD BLOOD COLLECTION UNIT 
sterile cord blood collection unit solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:79403-791
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE0.893 g  in 35 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) SODIUM CITRATE0.921 g  in 35 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID0.114 g  in 35 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE0.0078 g  in 35 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 35 g  in 35 mL
PHOSPHORIC ACID (UNII: E4GA8884NN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79403-791-0135 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDABN80022203/16/2011
Labeler - Global Life Sciences Solutions USA LLC (011658242)
Establishment
NameAddressID/FEIBusiness Operations
Haemonetics Manufacturing Inc.078598396manufacture(79403-791)

Revised: 12/2023
Document Id: 0cf56469-01ab-11ae-e063-6394a90af77b
Set id: aa9340b7-cc63-e17d-e053-2a95a90ad4d9
Version: 3
Effective Time: 20231220
 
Global Life Sciences Solutions USA LLC