Identity
- Trade Name
- ThermoChem FDA UDI
- Generic Name
- Intracavitary-circulation hyperthermia system FDA UDI
- Device Name
- The ThermoChem HT is a hyperthermia device that continuously circulates a heated sterile solution throughout the patients abdomen. The device accurately raises temperature to a predetermined target selected by the physician. FDA UDI
- Model / Reference
- HT-1000 FDA UDI
- Description
- The ThermoChem HT is a hyperthermia device that continuously circulates a heated sterile solution throughout the patients abdomen. The device accurately raises temperature to a predetermined target selected by the physician. FDA UDI
Identifiers
- Catalog Number
- HT-1000 FDA UDI
- Primary DI / UDI-DI
- 00851450007053 FDA UDI
- FDA Product Code
- MLW FDA UDI
- GMDN Term
- Intracavitary-circulation hyperthermia system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5630 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 — 330 Pound FDA UDIDepth — 26 Inch FDA UDIWidth — 29.5 Inch FDA UDIHeight — 69 Inch FDA UDI
Category: Intracavitary-circulation hyperthermia system
ThermoChem by Thermasolutions Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Thermasolutions Llc.
Sources (1)
- FDA UDI 76b6ea74-8148-4409-bc16-f9e2d2fc17ae 36 fields · synced May 30, 2026