Pall Sterile Cord Blood Collection Unit

Manufacturer
Global Life Sciences Solutions USA LLC | GVS TM INC | GVS TM, INC
Effective date
2025-12-18
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 21:51:39

Label at a glance#

ProductPall Sterile Cord Blood Collection Unit
Active ingredientSODIUM CITRATE, CITRIC ACID MONOHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE
Label structure7 sections

Indications and uses

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.

Label contents#

Full prescribing information#

WARNINGS

WARNINGS AND PRECAUTIONS 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.

HOW SUPPLIED

HOW SUPPLIED SECTION

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)

DESCRIPTION SECTION

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

This product is free of natural rubber latex.

Indications and Usage Section

INDICATIONS & 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

PRECAUTIONS SECTION

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

INFORMATION FOR PATIENTS SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bag labelBag labelEnvelope labelEnvelope labelCase LabelCase LabelIFUIFUIFUIFU

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)30636207307966(30)24(17)000000(10)0000000GTIN-14: 30636207307966
GTIN storage (14 digits): 30636207307966
791-08 - case.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79403-791-08Pall Sterile Cord Blood Collection Unit35 mL in 1 BAGSOLUTION357

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79403-79179403-791-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pall Sterile Cord Blood Collection UnitSTERILE CORD BLOOD COLLECTION UNITGlobal Life Sciences Solutions USA LLCaa9340b7-cc63-e17d-e053-2a95a90ad4d92025-12-18WarningsExact identifier
ndc (package): 79403-791-08
ndc (product): 79403-791
ndc11 (package): 79403079108
spl id: 46366161-f003-2826-e063-6394a90a91a5
spl set id: aa9340b7-cc63-e17d-e053-2a95a90ad4d9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.