Identity
- Trade Name
- ThermoChem FDA UDI
- Generic Name
- Intraperitoneal-circulation hypothermia system administration kit FDA UDI
- Device Name
- The IPH Procedure kit contains the sterile components needed to perform a hyperthermic lavage. The disposable items are intended for single use. The kit contains sterile tubing, inflow and outflow cannulae, temperature monitoring probes, heat exchanger and reservoir. FDA UDI
- Model / Reference
- IPH Procedure KIt FDA UDI
- Description
- The IPH Procedure kit contains the sterile components needed to perform a hyperthermic lavage. The disposable items are intended for single use. The kit contains sterile tubing, inflow and outflow cannulae, temperature monitoring probes, heat exchanger and reservoir. FDA UDI
Identifiers
- Catalog Number
- IPH-2000M FDA UDI
- Primary DI / UDI-DI
- 00851450007282 FDA UDI
- FDA Product Code
- MLW FDA UDI
- GMDN Term
- Intraperitoneal-circulation hypothermia system administration kit 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Depth — 8 Inch FDA UDIWidth — 15 Inch FDA UDILength — 30 Inch FDA UDIWeight — 11 Pound FDA UDI
Category: Intraperitoneal-circulation hypothermia system administration kit
ThermoChem by Thermasolutions 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
- Thermasolutions Llc.
Sources (1)
- FDA UDI c4607354-971d-43d7-8043-867783712d71 36 fields · synced May 30, 2026