Briostor™ Transfer/Freezing Bag Set

Basic Information

• Brand Name: Briostor™ Transfer/Freezing Bag Set
• Primary DI: 00636207314680
• Version / Model: 791-12
• Catalog Number: 791-12
• 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: 2016-07-20
• Public Version: 5
• Public Version Date: 2024-02-29
• Public Version Status: Update
• Public Device Record Key: d9cd9130-4928-4004-99d0-123e6881562f

Device Description

Five Chamber Transfer/Freezing Bag Set intended to be used for cord blood processing and freezing

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OAO	Cord blood processing system and storage container	Hematology	864.9900	2

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
Package	30636207314681	GS1	case	24	In Commercial Distribution
Primary	00636207314680	GS1

Customer Contacts

• Phone: [phone] ext. 5164843600
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
BK150314	0

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Five chamber transfer/freezing bag