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Sign in to claim this brandGentherm Medical, LLC
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 12011 MOSTELLER RD, Cincinnati, OH, 45241
- Website
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- —
- —
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 1516825
- DUNS Number
- —
Catalogue (83)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Electri-Cool ll | 767 | FDA UDI | Class II | Active |
| Penguin Cold Therapy® | 707 115V | FDA UDI | Class II | Active |
| FilteredFlo® Cardiac Blanket | 542 | FDA UDI | Class II | Active |
| Large Kool Kit® | 930 | FDA UDI | Class II | Active |
| Gelli-Roll® Infant Size | 193P | FDA UDI | Class II | Active |
| Cold Therapy Temp-Pads® | 1112-US | FDA UDI | Class II | Active |
| Cold Therapy Temp-Pads® | 814-IMB | FDA UDI | Class II | Active |
| InnerCool® STx™ System | 25-01 | FDA UDI | Class II | Active |
| Cold Therapy Temp-Pads® | 1112-NS | FDA UDI | Class II | Active |
| Plastipad® Narrow Adult/OR Table Size | 195N | FDA UDI | Class II | Active |
| Norm-O-Temp® | 111Z | FDA UDI | Class II | Active |
| Cold Therapy Temp-Pads® | 510-NS | FDA UDI | Class II | Active |
| Maxi-Therm®Lite | 873 | FDA UDI | Class II | Active |
| FilteredFlo® OR Blanket-Upper Body | 461 | FDA UDI | Class II | Active |
| FilteredFlo® Upper Body OR Blanket | 443 | FDA UDI | Class II | Active |
| WarmAir® 135 | 135 | FDA UDI | Class II | Active |
| Maxi-Therm® | 273 | FDA UDI | Class II | Active |
| Cold Therapy Temp-Pads® | CT-99NS | FDA UDI | Class II | Active |
| Maxi-Therm®Lite | 872 | FDA UDI | Class II | Active |
| FilteredFlo® Lower Body OR Blanket | 460 | FDA UDI | Class II | Active |
| FilteredFlo®Underbody Blanket | 247 | FDA UDI | Class II | Active |
| Cold Therapy Temp Pads® | CT-99NS | FDA UDI | Class II | Active |
| FilteredFlo® Torso Blanket | 344 | FDA UDI | Class II | Active |
| Cold Therapy Temp-Pads® | 814-USS | FDA UDI | Class II | Active |
| FilteredFlo® Underbody Blanket | 248 | FDA UDI | Class II | Active |
| FilteredFlo® PACU Adult Blanket | 243 | FDA UDI | Class II | Active |
| Plastipad® Infant Size | 193CPC | FDA UDI | Class II | Active |
| FilteredFlo® Neonate/Pediatric Blanket | 246 | FDA UDI | Class II | Active |
| Maxi-Therm®Lite | 871 | FDA UDI | Class II | Active |
| Warming Tube™ | 145 | FDA UDI | Class II | Active |
| Cold Therapy Temp-Pads® | 510-US | FDA UDI | Class II | Active |
| Penguin Cold Therapy® | 707 KST | FDA UDI | Class II | Active |
| Cold Therapy Temp-Pads® | 510-USS | FDA UDI | Class II | Active |
| Kool-Kit | 930-USME | FDA UDI | Class II | Active |
| FilteredFlo® Lower Body OR Blanket | 442 | FDA UDI | Class II | Active |
| Cold Therapy Temp-Pads® | N/A | FDA UDI | Class II | Active |
| Maxi-Therm® Lite Headwrap | 600 | FDA UDI | Class II | Active |
| Maxi-Therm®Lite | 876 | FDA UDI | Class II | Active |
| Blanketrol | 233 | FDA UDI | Class II | Active |
| Headwrap Kit | 910 | FDA UDI | Class II | Active |
| FilteredFlo® Pediatric Blanket | 244 | FDA UDI | Class II | Active |
| Kool-Kit | 920-USME | FDA UDI | Class II | Active |
| FilteredFlo® Pediatric Blanket | 244 | FDA UDI | Class II | Active |
| Hemotherm | 400CE | FDA UDI | Class II | Active |
| Cold Therapy Temp Pads® | 814-NS | FDA UDI | Class II | Active |
| FilteredFlo® Pediatric Blanket | 244 | FDA UDI | Class II | Active |
| Plastipad® Infant Size | 193 | FDA UDI | Class II | Active |
| Maxi-Therm®Lite | 870 | FDA UDI | Class II | Active |
| FilteredFlo® Neonate/Pediatric Blanket | 246 | FDA UDI | Class II | Active |
| Micro-Temp LT | 749 | FDA UDI | Class II | Active |
Related Companies
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 22, 2021 | Z-0496-2022 | — | terminated | This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads. |
| Jun 17, 2021 | Z-2092-2021 | — | terminated | There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the water systems of any heater-cooler device, and contaminated water from any heater-cooler device has the potential to aerosolize into the operating room during surgery which could lead to patient infection. |