Identity
- Trade Name
- CritiCool FDA UDI
- Generic Name
- External circulating-fluid core temperature regulation system control unit, heating/cooling FDA UDI
- Model / Reference
- 200-00236 FDA UDI
Identifiers
- Catalog Number
- 200-00236 FDA UDI
- Primary DI / UDI-DI
- 07290107581110 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: External circulating-fluid core temperature regulation system control unit, heating/cooling
CritiCool by Belmont Instrument Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External circulating-fluid core temperature regulation system control unit, heating/cooling.
- Arctic Sun® Temperature Management System, Temperature Cable Nellcor — Medivance, Inc. · Class II
- Arctic Sun® Temperature Management System, Temp Out Cable, Simms/Lemo Connector — Medivance, Inc. · Class II
- Arctic Sun® Temperature Management System, Drain Bag — Medivance, Inc. · Class II
- Arctic Sun® 5000 — Medivance, Inc. · Class II
- Arctic Sun® 5000 — Medivance, Inc. · Class II
- Arctic Sun® Temperature Management System, Strap Kit, Fluid Delivery Line — Medivance, Inc. · Class II
- warmUP — AVACORE TECHNOLOGIES, INC. · Class II
- Surface Warming & Cooling System — Adroit Medical Systems, Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Belmont Instrument Corp.
Sources (1)
- FDA UDI 760a7908-3322-42d8-8e6b-886f7b8cdf22 34 fields · synced May 30, 2026