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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
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1516825
- DUNS Number
- —
Catalogue (83)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Blanketrol® lll | 233 | FDA UDI | Class II | Active |
| FilteredFlo® PACU Adult Blanket | 243 | FDA UDI | Class II | Active |
| Kool Kit® | 900 | FDA UDI | Class II | Active |
| Maxi-Therm®Lite | 874 | FDA UDI | Class II | Active |
| Plastipad® Adult or OR Table Size | 196 | FDA UDI | Class II | Active |
| Maxi-Therm® | 276 | FDA UDI | Class II | Active |
| WarmAir® 135 | 135 | FDA UDI | Class II | Active |
| Gelli-Roll® Adult Size | 195P | FDA UDI | Class II | Active |
| FilteredFlo® PACU Adult Blanket | 243 | FDA UDI | Class II | Active |
| Maxi-Therm® | 274 | FDA UDI | Class II | Active |
| Cold Therapy Temp-Pads® | CT-99 | FDA UDI | Class II | Active |
| Plastipad® Pediatric Size | 194CPC | FDA UDI | Class II | Active |
| Maxi-Therm Lite | 876-USME | FDA UDI | Class II | Active |
| Gelli-Roll® Pediatric Size | 194P | FDA UDI | Class II | Active |
| Kool Kit® Neonate | 950 | FDA UDI | Class II | Active |
| Plastipad® Adult Size | 196CPC | FDA UDI | Class II | Active |
| Cold Therapy Temp-Pads® | 1112-USS | FDA UDI | Class II | Active |
| Kool-Kit | 900-USME | FDA UDI | Class II | Active |
| Cold Therapy Temp-Pads® | 814-US | FDA UDI | Class II | Active |
| Maxi-Therm Lite | 874-USME | FDA UDI | Class II | Active |
| Plastipad® Pediatric Size | 194 | FDA UDI | Class II | Active |
| Cold Therapy Temp-Pads® | 510-NS | FDA UDI | Class II | Active |
| Blanketrol | 233 | FDA UDI | Class II | Active |
| Cold Therapy Temp-Pads® | 1215-US | FDA UDI | Class II | Active |
| Cold Therapy Temp-Pads® | 814-NS | FDA UDI | Class II | Active |
| FilteredFlo® PACU Blanket | 462 | FDA UDI | Class II | Active |
| Kool-Kit | 950-USME | FDA UDI | Class II | Active |
| Maxi-Therm®Lite Patient Vest | 800 | FDA UDI | Class II | Active |
| Patient Vest Kit | 920 | FDA UDI | Class II | Active |
| Maxi-Therm Lite | 873-USME | FDA UDI | Class II | Active |
| Maxi-Therm®Lite Staff Vest | 300 | FDA UDI | Class II | Active |
| FilteredFlo® PACU Adult Blanket | 243 | FDA UDI | Class II | Unknown |
| Cold Therapy Temp-Pads® | 1112-NS | FDA UDI | Class II | Active |
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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. |