FROSTIME LLC

Address:1441 Broadway,New York City,NY,10018,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Refrigerator, Freezer, Blood Storage (KSE) (2)

Premarket Exempt

Yes

Clear

Frostmed LITE - 00860003258408 Catalog Number :

Device Description : Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 13 Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 13", 1 temperature probe, 2 CO2 canisters 1lb/each, Bluetooth module to communicate with an App

Device Class : 2

Duns Number: 079574775

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Frostmed PRO - 00860003258415 Catalog Number :

Device Description : Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 18 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