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Mistral-Air

FDA UDI

Class II (US FDA UDI)

by The Surgical Company International B.V.

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® Faceshield FDA UDI
Model / Reference
MA02010 FDA UDI
Description
Mistral-Air® Faceshield FDA UDI

Identifiers

Primary DI / UDI-DI
18719867001462 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

Similar devices

Also classified as External circulating-air core temperature regulation system pad, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
The Surgical Company International B.V.

Sources (1)

  • FDA UDI 61196b37-8a02-4091-b025-f04e0d61e933 33 fields · synced May 30, 2026