Identity
- Trade Name
- Mistral-Air® Adult Plus EUDAMEDMistral-Air FDA UDI
- Generic Name
- External circulating-air core temperature regulation system pad, single-use FDA UDI
- Device Name
- Mistral-Air® Tube EUDAMEDMistral-Air® Adult Plus FDA UDI
- Model / Reference
- MA0510 EUDAMEDMA2220 EUDAMEDFDA UDI
- Description
- Mistral-Air® Adult Plus FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18719867000540 EUDAMEDFDA UDI
- Basic UDI-DI
- 8719867EMDNT030301KX EUDAMED
- FDA Product Code
- DWJ FDA UDI
- EMDN Code
- T030301 AIR FLOW BLANKETS EUDAMED
- GMDN Term
- External circulating-air core temperature regulation system pad, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5900 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Mistral-Air® Adult Plus by The Surgical Company International B.V. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8719867EMDNT030301KX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- The Surgical Company International B.V.
- EUDAMED SRN
- NL-MF-000001973
Sources (2)
- EUDAMED 92014909-1988-4ef8-8a01-f797f6a140d8 61 fields · synced Jun 18, 2026
- FDA UDI 84a7eadd-896f-45c4-9249-4bf84f278d44 33 fields · synced May 30, 2026