AccessGUDID - DEVICE: CryoSC-Db Freezing Bag (07640125650402)

GUDID

Device Identifier (DI) Information

Brand Name: CryoSC-Db Freezing Bag
Version or Model: FB-100.2b
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 10041
Company Name: Biosafe S.A.

Primary DI Number: 07640125650402
Issuing Agency: GS1
Commercial Distribution End Date: November 21, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 488052341 *Terms of Use

Device Description: No description.

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":	No
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?
44904	Blood/tissue storage/culture container	A receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OOF	Cryogenic Cord Blood Storage Container

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK090037	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
No Device Sizes

Device Record Status

Public Device Record Key: a6777d70-8a8a-4f5c-862c-8e10b0e85b32
Public Version Date: November 28, 2022
Public Version Number: 6
DI Record Publish Date: January 13, 2017