Identity
- Trade Name
- Mistral-Air® Cardiac Plus Sterile EUDAMEDMistral-Air FDA UDI
- Generic Name
- External circulating-air core temperature regulation system pad, single-use FDA UDI
- Device Name
- Mistral-Air® Cardiac Plus sterile EUDAMEDMistral-Air Blanket, Cardiac Blanket Plus (sterile) FDA UDI
- Model / Reference
- MA2286 EUDAMEDFDA UDI
- Description
- Mistral-Air Blanket, Cardiac Blanket Plus (sterile) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18719867000908 EUDAMEDFDA UDI
- Basic UDI-DI
- B-18719867000908 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
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Mistral-Air® Cardiac Plus Sterile by The Surgical Company International B.V. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-18719867000908 | 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 a48a8bd5-fc62-4b78-8114-578fd04e67dc 61 fields · synced Oct 6, 2026
- FDA UDI dc2bf119-ae24-4ff9-8bec-d038f6754e15 33 fields · synced May 30, 2026