CAIRE Inc.

FDA UDI

Class II (US FDA UDI)

by Caire Inc.

Identity

Trade Name: CAIRE Inc. FDA UDI
Generic Name: Mobile/portable oxygen concentrator FDA UDI
Device Name: FreeStyle Comfort Oxygen Concentrator with autoSAT function, 2 single batteries FDA UDI
Model / Reference: AS200-241 FDA UDI
Description: FreeStyle Comfort Oxygen Concentrator with autoSAT function, 2 single batteries FDA UDI

Identifiers

Catalog Number: AS200-241 FDA UDI
Primary DI / UDI-DI: M766AS2002410 FDA UDI
510(k) Number: K250671 FDA UDI
FDA Product Code: CAW FDA UDI
GMDN Term: Mobile/portable oxygen concentrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5440 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Mobile/portable oxygen concentrator

CAIRE Inc. by Caire Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K250671 also covers:

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: Caire Inc.

Sources (1)

FDA UDI 52f03a70-9493-4175-b71a-03d20b4d8dbb 36 fields · synced May 30, 2026