Skip to content

FreeStyle AS095-1CU

by Caire Inc.

FreeStyle AS095-1CU is a Class II device made by Caire Inc., listed in FDA GUDID since 1 Jan 2016 (UDI-DI M766AS0951CU0), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM766AS0951CU0 UDI-DI Date1 Jan 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
FreeStyle
Generic name
Mobile/portable oxygen concentrator
Model / reference
AS095-1CU
Primary DI / UDI-DI
M766AS0951CU0
FDA product code
CAW
GMDN term
Mobile/portable oxygen concentrator
Device class
Class II
Regulation number
868.5440
GUDID distribution status
In Commercial Distribution

Related devices

Category: Mobile/portable oxygen concentrator

Similar devices in this category

Other devices filed under Mobile/portable oxygen concentrator.

Other devices from Caire Inc.

  • Spirit

    Class IIa

  • Stroller 10998054

    Class II

  • Stroller 10564125

    Class II

  • Stroller 14770508

    Class II

See all devices from Caire Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)