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) (4)

Premarket Exempt

No Yes

Clear

FilteredFlo® Torso Blanket - 20613031833444 Catalog Number : 83344

Device Description : Thermal Regulating System

Device Class :

Duns Number: 004249462

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 10

FilteredFlo® Lower Body OR Blanket - 20613031834427 Catalog Number : 83442

Device Description : WarmAir 135 patient warming system.

Device Class :

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 10

FilteredFlo® PACU Adult Blanket - 20613031842439 Catalog Number : 84243

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 - 20613031842446 Catalog Number : 84244

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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