AccessGUDID - DEVICE: Frostmed PRO (00860003258415)

GUDID

Device Identifier (DI) Information

Brand Name: Frostmed PRO
Version or Model: V 1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FROSTIME LLC

Primary DI Number: 00860003258415
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079574775 *Terms of Use

Device Description: Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 18", 1 temperature probe, 2 CO2 canisters 2.5lb/each, Bluetooth module to communicate with an App

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?
63325	Laboratory refrigerator/freezer	A mains electricity (AC-powered) appliance designed for the storage of laboratory products, specimens, cultures, reagents and other laboratory materials both at refrigerated temperatures (typically 1° to 6° Celsius) and in a frozen state (typically -18° to -30° Celsius). It includes refrigeration and freezing compartments with internal shelving, controls, sensors and alarms to signal out-of-range temperatures and power failures; its interior is typically corrosion-resistant to minimize the risk of adulteration, contamination, and/or corrosion of contents. The refrigeration unit is typically equipped with a safety thermostat to protect the products from freezing.	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: 8b3ae070-b56d-4919-95c6-398a360c2650
Public Version Date: February 05, 2020
Public Version Number: 2
DI Record Publish Date: January 23, 2020