Anticoagulant Citrate Phosphate Dextrose Solution (CPD)

Basic Information

• Brand Name: Anticoagulant Citrate Phosphate Dextrose Solution (CPD)
• Primary DI: 30636207307966
• Version / Model: 791-08
• Catalog Number: 791-08
• Company Name: Global Life Sciences Solutions USA LLC
• Labeler DUNS: 011658242
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-02
• Public Version: 2
• Public Version Date: 2024-02-29
• Public Version Status: Update
• Public Device Record Key: 130e8606-1cce-4eb8-90a5-7ff4c976c8ed
• Distribution End Date: 2099-10-03

Device Description

For the collection of umbilical cord blood from either a vaginal birth or within the sterile field of a cesarean section.Anticoagulant type and volume are specifically selected for cord blood collection to ensure a robust and easy-to-use process. Bag with 250 mL fill volume. Set contains 35 mL of Citrate Phosphate Dextrose (CPD) anticoagulant. Permits the collection of up to 210 mL of cord blood. The cord blood is usually intended to be frozen and stored, typically to preserve stem cells, for subsequent reinfusion into patients, generally in cases of leukemia. This is a single-use device.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
47115	Umbilical cord blood collection set	A group of devices intended to be used to collect, process, and store umbilical cord blood and/or umbilical cord blood components (e.g., buffy coat). It typically includes tubing, hollow needles for insertion into the umbilical cord (a double venipuncture of the cord) to collect the blood, and several containers (flexible bags usually containing an anticoagulant) intended for transitional (room temperature) or long-term (frozen) blood storage. The cord blood is usually intended to be frozen and stored, typically to preserve stem cells, for subsequent reinfusion into patients, generally in cases of leukaemia. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30636207307966	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]