Identity
- Trade Name
- CritiCool Pro FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- Thermoregulation System combined with patient monitor FDA UDI
- Model / Reference
- VL4000M 115VAC FDA UDI
- Description
- Thermoregulation System combined with patient monitor FDA UDI
Identifiers
- Catalog Number
- 100-00113 FDA UDI
- Primary DI / UDI-DI
- 07290107580540 FDA UDI
- FDA Product Code
- DWJ FDA UDI
- GMDN Term
- General-purpose multi-parameter bedside monitor 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
Yes
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: General-purpose multi-parameter bedside monitorExternal circulating-fluid core temperature regulation system control unit, heating/cooling
CritiCool Pro by M.t.r.e. Advanced Technologies Ltd. — 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
- M.t.r.e. Advanced Technologies Ltd.
Sources (1)
- FDA UDI 6ebd39fc-c781-4af0-b52d-b27173fd3071 35 fields · synced Jun 8, 2026