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Liberator

by CAIRE Inc. 17 variants

Ref 13256654

Liberator (13256654) is a stationary liquid oxygen container (EU MDD Class IIa; FDA Class II; FDA product code BYJ, Unit, Liquid-Oxygen, Portable) made by Caire Inc., registered in EUDAMED on 1 Apr 2025 (Basic UDI-DI B-M766132566540), cleared under FDA 510(k) K800742 on 23 May 1980 and listed in FDA GUDID since 29 Aug 2016 (UDI-DI M766132566540), active as of 22 Oct 2026. 4 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

4 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K800742

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-M766132566540 Basic UDI-DI M766132566540UDI-DIDate1 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID NumberM766132566540 UDI-DI Date29 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK800742 Date23 May 1980DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-M766132566540 registered 1 Apr 2025 Active
  • FDA 510(k) K800742 decided 23 May 1980 Active
  • FDA GUDID UDI-DI M766132566540 listed 29 Aug 2016 Listed

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0337-2023 FDA Class I initiated 10 Oct 2022
    • Terminated Z-0338-2023 FDA Class I initiated 10 Oct 2022
    • Terminated Z-0339-2023 FDA Class I initiated 10 Oct 2022
    • Terminated Z-0336-2023 FDA Class I initiated 10 Oct 2022

    An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.

Timeline

7 dated events

  1. Cleared FDA 510(k) K800742
  2. Listed FDA GUDID M766132566540
  3. Recall initiated FDA recalls Z-0337-2023
  4. Recall initiated FDA recalls Z-0338-2023
  5. Recall initiated FDA recalls Z-0339-2023
  6. Recall initiated FDA recalls Z-0336-2023
  7. Registered EUDAMED B-M766132566540

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Stationary liquid oxygen container
Model / reference
13256654
Primary DI / UDI-DI
M766132566540
Basic UDI-DI
B-M766132566540
510(k) Number
FDA product code
BYJ
EMDN code
R9099 Respiratory and anaesthesia devices - other
GMDN term
Stationary liquid oxygen container
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5655
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000013030
Authorised representative
MPS Medical Product Service GmbH DE-AR-000005009

Related devices

Category: Pulmonary function analysis system, adult

Similar devices in this category

Other devices filed under RESPIRATORY AND ANAESTHESIA DEVICES - OTHER.

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See all devices from Caire Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)