Identity
- Trade Name
- Mistral-Air FDA UDI
- Generic Name
- External circulating-air core temperature regulation system pad, single-use FDA UDI
- Device Name
- Mistral-Air® Tube - SYK FDA UDI
- Model / Reference
- MA0510-PM FDA UDI
- Description
- Mistral-Air® Tube - SYK FDA UDI
Identifiers
- Primary DI / UDI-DI
- ET37MA0510PM0 FDA UDI
- 510(k) Number
- K101705 FDA UDI
- FDA Product Code
- DWJ FDA UDI
- GMDN Term
- External circulating-air core temperature regulation system pad, single-use 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: External circulating-air core temperature regulation system pad, single-use
Mistral-Air by The Surgical Company International B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K101705 also covers:
- Mistral Air — The Surgical Company International B.V.
- Mistral Air — The Surgical Company International B.V.
- Mistral Air — The Surgical Company International B.V.
- Mistral Air — The Surgical Company International B.V.
- Mistral-Air — The Surgical Company International B.V.
- Mistral-Air — The Surgical Company International B.V.
- Mistral-Air — The Surgical Company International B.V.
- Mistral-Air — The Surgical Company International B.V.
- Mistral-Air — The Surgical Company International B.V.
- Mistral-Air — The Surgical Company International B.V.
- Mistral-Air — The Surgical Company International B.V.
- Mistral-Air — The Surgical Company International B.V.
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
- The Surgical Company International B.V.
Sources (1)
- FDA UDI 1ce5b6cd-3fe0-4893-afa0-3b3bc55e0ccd 34 fields · synced May 29, 2026