Identity
- Trade Name
- ThermoWrap™ Universal, 104–122cm (single) FDA UDI
- Generic Name
- External circulating-fluid core temperature regulation system control unit, heating/cooling FDA UDI
- Device Name
- Accessory for the Allon 2001 systems. A body wrap connected to the thermoregulation system. FDA UDI
- Model / Reference
- 500-03141 FDA UDI
- Description
- Accessory for the Allon 2001 systems. A body wrap connected to the thermoregulation system. FDA UDI
Identifiers
- Catalog Number
- 500-03141 FDA UDI
- Primary DI / UDI-DI
- 07290012127229 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: External circulating-fluid core temperature regulation system control unit, heating/cooling
ThermoWrap™ Universal, 104–122cm (single) by Belmont Instrument Corp. — 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
- Belmont Instrument Corp.
Sources (1)
- FDA UDI beeaaae3-3b6f-44fb-969c-57afdad34159 34 fields · synced Jun 1, 2026