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

System, Thermal Regulating (DWJ) (5) Pack, Hot Or Cold, Water Circulating (ILO) (4) Controller, Temperature, Cardiopulmonary Bypass (DWC) (1)

Premarket Exempt

No Yes

Clear

Gelli-Roll® Adult Size - 10613031821994 Catalog Number : 82199

Device Description : Water Circulating Hot or Cold Pack

Device Class : 2

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

FilteredFlo® PACU Adult Blanket - 10613031822434 Catalog Number : 82243

Device Description : Thermal Regulating System

Device Class :

Duns Number: 004249462

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 10

InnerCool® STx™ System - 10613031860009 Catalog Number : 86000

Device Description : Temperature management system used to lower or raise a patient's temperature and Temperature management system used to lower or raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer.

Device Class : 2

Duns Number: 004249462

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Hemotherm - 10613031860221 Catalog Number : 86022

Device Description : Hemotherm® Dual Reservoir Cooler/Heater (115V, 50Hz)

Device Class : 2

Duns Number: 004249462

Premarket Exempt : No

Product Code : DWC

Prescription Use : Yes

Device Count : 1

Blanketrol® lll - 10613031861075 Catalog Number : 86107

Device Description : Thermal Regulating System

Device Class : 2

Duns Number: 004249462

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Norm-O-Temp® - 10613031861549 Catalog Number : 86154

Device Description : Total Body Hyperthermia System

Device Class : 2

Duns Number: 004249462

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

WarmAir® 135 - 10613031861860 Catalog Number : 86186

Device Description : Convective Warming System

Device Class : 2

Duns Number: 004249462

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Electri-Cool ll - 10613031861938 Catalog Number : 86193

Device Description : The Electri-Cool® II System is intended to provide cold therapy.

Device Class : 2

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Penguin Cold Therapy® - 10613031862430 Catalog Number : 86243

Device Description : Cold Therapy Device

Device Class : 2

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : No

Device Count : 1

Penguin Cold Therapy® - 10613031862454 Catalog Number : 86245

Device Description : Cold Therapy Device

Device Class : 2

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : No

Device Count : 1

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