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Gentherm Medical, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
15168251516825Gentherm Medical, LLC1Y2026-01-0112011 MOSTELLER RD Cincinnati OH US 45241

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
20613031838739Maxi-Therm Lite - Thermal Regulation Pad8009897373CSZ@genthermCSZ.com
20613031838746Maxi-Therm Lite - Thermal Regulation Pad8009897373CSZ@genthermCSZ.com
20613031838760Maxi-Therm Lite - Thermal Regulation Pad8009897373CSZ@genthermCSZ.com
20613031839002Kool-Kit - Thermal Regulation Pad8009897373CSZ@genthermCSZ.com
20613031839200Kool-Kit - Thermal Regulation Pad8009897373CSZ@genthermCSZ.com
20613031839309Kool-Kit - Thermal Regulation Pad8009897373CSZ@genthermCSZ.com
20613031839507Kool-Kit - Body Temperature Regulation Pad8009897373CSZ@genthermCSZ.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
317721832446941K232638FilteredFlo Warming BlanketsDWJ2023-10-24
317721986031799K231596IOB Temperature Management SystemDWJ2023-06-30
317721212911093K123946WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETSDWJ2013-01-17
317721422723212K122813HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEMDWC2012-12-18
317721789161976K120081NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADSDWJ2012-02-17
317721131705869K101589BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMSDWJ2010-09-20
317721219893977
317721857480418

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DWJ52023-10-24
DWC12012-12-18

GUDID#

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