Identity
- Trade Name
- ThermaZone FDA UDI
- Generic Name
- Circulating-fluid localized thermal therapy system pack, single-use FDA UDI
- Device Name
- ThermaZone Single Patient Use Small Shoulder Pad FDA UDI
- Model / Reference
- 003-31 FDA UDI
- Description
- ThermaZone Single Patient Use Small Shoulder Pad FDA UDI
Identifiers
- Catalog Number
- 003-31 FDA UDI
- Primary DI / UDI-DI
- 00854682001912 FDA UDI
- FDA Product Code
- ILO FDA UDI
- GMDN Term
- Circulating-fluid localized thermal therapy system pack, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Circulating-fluid localized thermal therapy system pack, single-use
ThermaZone by Innovative Medical Equipment — 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
- Innovative Medical Equipment
Sources (1)
- FDA UDI 60fb4078-597c-403e-a6e5-7f8f5c68e68f 36 fields · synced May 30, 2026