Anticoagulant Citrate Phosphate Dextrose Solution (Cpd)
Sterile, non-pyrogenic fluid path. Sterilized by steam.
This product is free of natural rubber latex.
Pall Sterile Cord Blood Collection Unit Solution
FDA Label NDC 79403-791
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Global Life Sciences Solutions Usa Llc for the product Pall Sterile Cord Blood Collection Unit (NDC 79403-791). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding anticoagulant citrate phosphate dextrose solution (cpd), indications and usage section, warnings section, general precautions, how supplied, information for patients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- 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.
- Using aseptic technique, insert needle into umbilical vein, disengage Pinch Clamp to collect cord blood, mixing frequently, according to standard procedures.
- 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.
- 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.
- When the tubing has been drained, hold tubing vertical and seal tubing directly below the Y-piece with air vent.
- Detach and discard needle, DCNG, Pinch Clamp, Air Vent and tubing according to standard procedures.
- 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.
- Mix well. Take care to strip and mix any blood in tubing.
- Load bag into centrifuge cup. It is suggested that a means of support is used to prevent bag from collapsing and to reduce wrinkles.
- Centrifuge according to standard procedures to obtain mononuclear cell-rich plasma.
Package Label.Principal Display Panel
Ifu (Ifu)
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