Frostmed PRO

Basic Information

• Brand Name: Frostmed PRO
• Primary DI: 00860003258415
• Version / Model: V 1.0
• Company Name: FROSTIME LLC
• Labeler DUNS: 079574775
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-23
• Public Version: 2
• Public Version Date: 2020-02-05
• Public Version Status: Update
• Public Device Record Key: 8b3ae070-b56d-4919-95c6-398a360c2650

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

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSE	Refrigerator, Freezer, Blood Storage	Hematology	864.9700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860003258415	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]