Identity
- Trade Name
- Blanketrol® lll FDA UDI
- Generic Name
- External circulating-fluid core temperature regulation system control unit, heating/cooling FDA UDI
- Device Name
- Thermal Regulating System FDA UDI
- Model / Reference
- 233 FDA UDI
- Description
- Thermal Regulating System FDA UDI
Identifiers
- Catalog Number
- 86107 FDA UDI
- Primary DI / UDI-DI
- 10613031861075 FDA UDI
- FDA Product Code
- DWJ FDA UDI
- GMDN Term
- External circulating-fluid core temperature regulation system control unit, heating/cooling FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 59.5 Kilogram FDA UDIWeight — 131 Pound FDA UDIHeight — 95.3 Centimeter FDA UDIDepth — 43.2 Centimeter FDA UDIWidth — 43.2 Centimeter FDA UDIHeight — 37.5 Inch FDA UDIDepth — 17.0 Inch FDA UDIWidth — 17.0 Inch FDA UDI
Category: External circulating-fluid core temperature regulation system control unit, heating/cooling
Blanketrol® lll by Gentherm Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Gentherm Medical, LLC
Sources (1)
- FDA UDI 7fd2503c-984f-4587-ae00-2445c24c61dc 37 fields · synced May 30, 2026