Identity
- Trade Name
- TECOtherm FDA UDI
- Generic Name
- External circulating-fluid core temperature regulation system control unit, heating/cooling FDA UDI
- Model / Reference
- NEO FDA UDI
Identifiers
- Catalog Number
- 8289830 FDA UDI
- Primary DI / UDI-DI
- 04260647540314 FDA UDI
- 510(k) Number
- K140078 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
No
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
Category: External circulating-fluid core temperature regulation system control unit, heating/cooling
TECOtherm by Tec Com Medizintechnik GmbH — 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
- Tec Com Medizintechnik GmbH
Sources (1)
- FDA UDI 146b4f7c-fea0-4545-8970-dc01296a8b4a 35 fields · synced Jun 1, 2026