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

FilteredFlo® PACU Blanket - 20613031824626 Catalog Number : 82462

Device Description : Thermal Regulating System

Device Class :

Duns Number: 004249462

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 40

Cold Therapy Temp-Pads® - 20613031825104 Catalog Number : 82510

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® Cardiac Blanket - 20613031825425 Catalog Number : 82542

Device Description : Thermal Regulating System

Device Class :

Duns Number: 004249462

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 5

Maxi-Therm® Lite Headwrap - 20613031826002 Catalog Number : 82600

Device Description : Thermal Regulating System

Device Class :

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 10

Maxi-Therm®Lite Patient Vest - 20613031828006 Catalog Number : 82800

Device Description : Hyper-Hypothermia Blanket

Device Class :

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 5

Cold Therapy Temp Pads® - 20613031828143 Catalog Number : 82814

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

Maxi-Therm®Lite - 20613031828709 Catalog Number : 82870

Device Description : Hyper-Hypothermia Blankets

Device Class :

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 10

Maxi-Therm®Lite - 20613031828716 Catalog Number : 82871

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 - 20613031828723 Catalog Number : 82872

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 - 20613031828730 Catalog Number : 82873

Device Description : Hyper-Hypothermia Blanket

Device Class :

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 10

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