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) (7) System, Thermal Regulating (DWJ) (3)

Premarket Exempt

No Yes

Clear

Cold Therapy Temp-Pads® - 20613031506515 Catalog Number : 50651

Device Description : Water Circulating Hot or Cold Pack

Device Class :

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 5

Cold Therapy Temp-Pads® - 20613031507338 Catalog Number : 50733

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® - 20613031507345 Catalog Number : 50734

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® - 20613031507352 Catalog Number : 50735

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® - 20613031507376 Catalog Number : 50737

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

FilteredFlo® PACU Adult Blanket - 20613031812432 Catalog Number : 81243

Device Description : Thermal Regulating System

Device Class : 2

Duns Number: 004249462

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 10

FilteredFlo® Pediatric Blanket - 20613031812449 Catalog Number : 81244

Device Description : Thermal Regulating System

Device Class : 2

Duns Number: 004249462

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 10

Cold Therapy Temp Pads® - 20613031820994 Catalog Number : 82099

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® - 20613031821113 Catalog Number : 82111

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

Warming Tube™ - 20613031821458 Catalog Number : 82145

Device Description : Thermal Regulating System

Device Class :

Duns Number: 004249462

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 25

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