Gentherm Medical L L C

FDA Filings

This page includes the latest FDA filings for Gentherm Medical L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1516825
FEI Number1516825
NameGentherm Medical, LLC
Owner & OperatorGentherm Medical LLC
Contact Address12011 MOSTELLER RD. 3rd Floor
Cincinnati OH 45241 US
Official Correspondent
  • CHRISTINA M MIRACLE
  • 1-513-3265295-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address12011 MOSTELLER RD 3rd Floor
Blue Ash, OH 45241 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only



FDA Filings

Device
Company
DeviceDate
Gentherm Medical, LLC
Blanketrol 871072024-07-03
Gentherm Medical, LLC
Blanketrol 2332024-05-21
Gentherm Medical, LLC
Kool-Kit 950-USME2024-05-21
Gentherm Medical, LLC
Kool-Kit 930-USME2024-05-21
Gentherm Medical, LLC
Kool-Kit 920-USME2024-05-21
Gentherm Medical, LLC
Kool-Kit 900-USME2024-05-21
Gentherm Medical, LLC
Maxi-Therm Lite 876-USME2024-05-21
Gentherm Medical, LLC
Maxi-Therm Lite 874-USME2024-05-21
Gentherm Medical, LLC
Maxi-Therm Lite 873-USME2024-05-21
Gentherm Medical, LLC
FilteredFlo® Pediatric Blanket 842442022-08-30
Gentherm Medical, LLC
FilteredFlo® PACU Adult Blanket 842432022-08-30
Gentherm Medical, LLC
FilteredFlo® Neonate/Pediatric Blanket 832462022-08-30
Gentherm Medical, LLC
FilteredFlo® Pediatric Blanket 812442022-08-30
Gentherm Medical, LLC
FilteredFlo® PACU Adult Blanket 812432022-08-30
Gentherm Medical, LLC
WarmAir® 135 863862021-11-24
Gentherm Medical, LLC
Micro-Temp LT 881162021-09-23
Gentherm Medical, LLC
Penguin Cold Therapy® 862452021-09-23
Gentherm Medical, LLC
Penguin Cold Therapy® 862432021-09-23
Gentherm Medical, LLC
Electri-Cool ll 861932021-09-23
Gentherm Medical, LLC
WarmAir® 135 861862021-09-23
Gentherm Medical, LLC
Norm-O-Temp® 861542021-09-23
Gentherm Medical, LLC
Blanketrol® lll 861072021-09-23
Gentherm Medical, LLC
InnerCool® STx™ System 860002021-09-23
Gentherm Medical, LLC
Gelli-Roll® Adult Size 821992021-09-23
Gentherm Medical, LLC
Gelli-Roll® Pediatric Size 821982021-09-23
Gentherm Medical, LLC
Gelli-Roll® Infant Size 821972021-09-23
Gentherm Medical, LLC
Plastipad® Adult or OR Table Size 821962021-09-23
Gentherm Medical, LLC
Plastipad® Pediatric Size 821942021-09-23
Gentherm Medical, LLC
Plastipad® Infant Size 821932021-09-23
Gentherm Medical, LLC
Plastipad® Infant Size 821922021-09-23
Gentherm Medical, LLC
Plastipad® Adult Size 821842021-09-23
Gentherm Medical, LLC
Cold Therapy Temp-Pads® 507152021-09-23
Gentherm Medical, LLC
Plastipad® Pediatric Size 501112021-09-23
Gentherm Medical, LLC
Plastipad® Narrow Adult/OR Table Size 501032021-09-23

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