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) (8) Pack, Hot Or Cold, Water Circulating (ILO) (2)

Premarket Exempt

No Yes

Clear

Maxi-Therm®Lite - 20613031828747 Catalog Number : 82874

Device Description : Hyper-Hypothermia Blanket

Device Class :

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 10

Maxi-Therm®Lite - 20613031828761 Catalog Number : 82876

Device Description : Hyper-Hypothermia Blanket

Device Class :

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 10

Kool Kit® - 20613031829003 Catalog Number : 82900

Device Description : Thermal Regulating System

Device Class :

Duns Number: 004249462

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 5

Headwrap Kit - 20613031829102 Catalog Number : 82910

Device Description : Thermal Regulating System

Device Class :

Duns Number: 004249462

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 5

Patient Vest Kit - 20613031829201 Catalog Number : 82920

Device Description : Thermal Regulating System

Device Class :

Duns Number: 004249462

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 5

Large Kool Kit® - 20613031829300 Catalog Number : 82930

Device Description : Thermal Regulating System

Device Class :

Duns Number: 004249462

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 5

Kool Kit® Neonate - 20613031829508 Catalog Number : 82950

Device Description : Thermal Regulating System

Device Class :

Duns Number: 004249462

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 5

FilteredFlo® PACU Adult Blanket - 20613031832430 Catalog Number : 83243

Device Description : Thermal Regulating System

Device Class :

Duns Number: 004249462

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 10

FilteredFlo® Pediatric Blanket - 20613031832447 Catalog Number : 83244

Device Description : Thermal Regulating System

Device Class :

Duns Number: 004249462

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 10

FilteredFlo® Neonate/Pediatric Blanket - 20613031832461 Catalog Number : 83246

Device Description : Thermal Regulating System

Device Class : 2

Duns Number: 004249462

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 10

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