AccessGUDID - DEVICE: Briostor™ Transfer/Freezing Bag Set (00636207314680)

GUDID

Device Identifier (DI) Information

Brand Name: Briostor™ Transfer/Freezing Bag Set
Version or Model: 791-12
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 791-12
Company Name: Global Life Sciences Solutions USA LLC

Primary DI Number: 00636207314680
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011658242 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAO	Cord blood processing system and storage container

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK150314	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: d9cd9130-4928-4004-99d0-123e6881562f
Public Version Date: February 29, 2024
Public Version Number: 5
DI Record Publish Date: July 20, 2016