AccessGUDID - DEVICE: Thermo Scientific ™ CryoMed™ (00815773020373)

GUDID

Device Identifier (DI) Information

Brand Name: Thermo Scientific ™ CryoMed™
Version or Model: TSCM48MV
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TSCM48MV
Company Name: THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC

Primary DI Number: 00815773020373
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 791530061 *Terms of Use

Device Description: TSCM48MV; CryoMed MD 48L w/o print, 230v/50Hz

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:	No
Prescription Use (Rx):	No
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?
22073	Cryogenic laboratory freezer, liquid nitrogen	An electrically-powered laboratory appliance designed for extended cell/tissue (e.g., ovum, embryo, bone, cornea) storage, at temperatures below the point when most all biological activity ceases, using liquid nitrogen (LN2) as the cooling and storage agent. LN2 storage provides a temperature of -180° Celsius (-292° Fahrenheit) or colder. The device typically consists of a chamber with two vessels separated by a vacuum space; automatic temperature controls; an external container to replenish the cryogenic fluid; a pressure-relief device, alarm, recorder; and a pressure-control valve. Cells/tissues are immersed in the liquid nitrogen using appropriate sealed containers.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSE	Refrigerator, Freezer, Blood Storage

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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: 8be74271-d1dc-4517-885d-2fcde1ac3f0c
Public Version Date: December 11, 2024
Public Version Number: 2
DI Record Publish Date: January 05, 2021