AirSep FreeStyle 5

FDA UDI

Class II (US FDA UDI)

by Caire Inc.

Identity

Trade Name: AirSep FreeStyle 5 FDA UDI
Generic Name: Mobile/portable oxygen concentrator FDA UDI
Device Name: AirSep FreeStyle 5 Portable Oxygen Concentrator, 1-5LPM, External Battery, Re-Manufactured FDA UDI
Model / Reference: AS077-101CU FDA UDI
Description: AirSep FreeStyle 5 Portable Oxygen Concentrator, 1-5LPM, External Battery, Re-Manufactured FDA UDI

Identifiers

Primary DI / UDI-DI: M766AS077101CU0 FDA UDI
510(k) Number: K020324 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

Category: Mobile/portable oxygen concentrator

AirSep FreeStyle 5 by Caire Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K020324 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 c6736135-abed-4330-a036-fe8a5e1fb730 34 fields · synced May 30, 2026