Identity
- Trade Name
- Surface Warming & Cooling System FDA UDI
- Generic Name
- External circulating-fluid core temperature regulation system control unit, heating/cooling FDA UDI
- Device Name
- Surface Warming & Cooling System FDA UDI
- Model / Reference
- A3 FDA UDI
- Description
- Surface Warming & Cooling System FDA UDI
Identifiers
- Catalog Number
- 3102-0001 FDA UDI
- Primary DI / UDI-DI
- 10615089310208 FDA UDI
- FDA Product Code
- ILO 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
- 890.5720 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
Yes
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
Surface Warming & Cooling System by Adroit Medical Systems, Inc. — 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
- Adroit Medical Systems, Inc.
Sources (1)
- FDA UDI dc7e36d6-6b41-4ae8-b360-d4e991f071a7 34 fields · synced Jun 9, 2026