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 Number: 1516825
• FEI Number: 1516825
• Name: Gentherm Medical, LLC
• Owner & Operator: Gentherm Medical LLC
• Contact Address: 12011 MOSTELLER RD. 3rd Floor; Cincinnati OH 45241 US
• Official Correspondent:
  • CHRISTINA M MIRACLE
  • 1-513-3265295-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 12011 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	Device	Date
GUDID 10613031842449 Gentherm Medical, LLC	FilteredFlo® Pediatric Blanket 84244	2022-08-30
GUDID 10613031842432 Gentherm Medical, LLC	FilteredFlo® PACU Adult Blanket 84243	2022-08-30
GUDID 10613031832464 Gentherm Medical, LLC	FilteredFlo® Neonate/Pediatric Blanket 83246	2022-08-30
GUDID 10613031812442 Gentherm Medical, LLC	FilteredFlo® Pediatric Blanket 81244	2022-08-30
GUDID 10613031812435 Gentherm Medical, LLC	FilteredFlo® PACU Adult Blanket 81243	2022-08-30
GUDID 10613031863864 Gentherm Medical, LLC	WarmAir® 135 86386	2021-11-24
GUDID 10613031881165 Gentherm Medical, LLC	Micro-Temp LT 88116	2021-09-23
GUDID 10613031862454 Gentherm Medical, LLC	Penguin Cold Therapy® 86245	2021-09-23
GUDID 10613031862430 Gentherm Medical, LLC	Penguin Cold Therapy® 86243	2021-09-23
GUDID 10613031861938 Gentherm Medical, LLC	Electri-Cool ll 86193	2021-09-23
GUDID 10613031861860 Gentherm Medical, LLC	WarmAir® 135 86186	2021-09-23
GUDID 10613031861549 Gentherm Medical, LLC	Norm-O-Temp® 86154	2021-09-23
GUDID 10613031861075 Gentherm Medical, LLC	Blanketrol® lll 86107	2021-09-23
GUDID 10613031860009 Gentherm Medical, LLC	InnerCool® STx™ System 86000	2021-09-23
GUDID 10613031821994 Gentherm Medical, LLC	Gelli-Roll® Adult Size 82199	2021-09-23
GUDID 10613031821987 Gentherm Medical, LLC	Gelli-Roll® Pediatric Size 82198	2021-09-23
GUDID 10613031821970 Gentherm Medical, LLC	Gelli-Roll® Infant Size 82197	2021-09-23
GUDID 10613031821963 Gentherm Medical, LLC	Plastipad® Adult or OR Table Size 82196	2021-09-23
GUDID 10613031821949 Gentherm Medical, LLC	Plastipad® Pediatric Size 82194	2021-09-23
GUDID 10613031821932 Gentherm Medical, LLC	Plastipad® Infant Size 82193	2021-09-23
GUDID 10613031821925 Gentherm Medical, LLC	Plastipad® Infant Size 82192	2021-09-23
GUDID 10613031821840 Gentherm Medical, LLC	Plastipad® Adult Size 82184	2021-09-23
GUDID 10613031507157 Gentherm Medical, LLC	Cold Therapy Temp-Pads® 50715	2021-09-23
GUDID 10613031501117 Gentherm Medical, LLC	Plastipad® Pediatric Size 50111	2021-09-23
GUDID 10613031501032 Gentherm Medical, LLC	Plastipad® Narrow Adult/OR Table Size 50103	2021-09-23

Related Finance Registrations

NCAGE Code	99920	GENTHERM MEDICAL, LLC
CAGE Code	99920	GENTHERM MEDICAL, LLC
S.A.M. Registration	99920 [4249462]	GENTHERM MEDICAL, LLC