Gentherm Medical, LLC

Address:12011 MOSTELLER RD,Cincinnati,OH,45241,US

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Filters

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

Pack, Hot Or Cold, Water Circulating (ILO) (9) System, Thermal Regulating (DWJ) (1)

Premarket Exempt

No Yes

Clear

WarmAir® 135 - 10613031863864 Catalog Number : 86386

Device Description : Convective Warming System

Device Class : 2

Duns Number: 004249462

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Micro-Temp LT - 10613031881165 Catalog Number : 88116

Device Description : MICRO-TEMP® LT Model 749 Localized Heat Therapy System.

Device Class : 2

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Cold Therapy Temp-Pads® - 20613031501374 Catalog Number : 50137

Device Description : Water Circulating Hot or Cold Pack

Device Class :

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 10

Cold Therapy Temp-Pads® - 20613031506256 Catalog Number : 50625

Device Description : Water Circulating Hot or Cold Pack

Device Class :

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 10

Cold Therapy Temp-Pads® - 20613031506270 Catalog Number : 50627

Device Description : Water Circulating Hot or Cold Pack

Device Class :

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 10

Cold Therapy Temp-Pads® - 20613031506287 Catalog Number : 50628

Device Description : Water Circulating Hot or Cold Pack

Device Class :

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 10

Cold Therapy Temp-Pads® - 20613031506294 Catalog Number : 50629

Device Description : Water Circulating Hot or Cold Pack

Device Class :

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 10

Cold Therapy Temp-Pads® - 20613031506331 Catalog Number : 50633

Device Description : Water Circulating Hot or Cold Pack

Device Class :

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 10

Cold Therapy Temp-Pads® - 20613031506348 Catalog Number : 50634

Device Description : Water Circulating Hot or Cold Pack

Device Class :

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 10

Cold Therapy Temp-Pads® - 20613031506355 Catalog Number : 50635

Device Description : Water Circulating Hot or Cold Pack

Device Class :

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 10

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