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Invacare® Platinum Oxygen Concentrator IRC9LXO2AWQL5

by Invacare Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841447114635 UDI-DI Date21 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-0872-2015 FDA Class II initiated 31 Oct 2014

    The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard.

    • Terminated Z-0577-2015 FDA Class II initiated 23 Sep 2014

    It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the sieve beds to migrate into the valves of the manifold assembly and muffler causing a reduction in oxygen concentration.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Invacare® Platinum Oxygen Concentrator
Generic Name
Stationary oxygen concentrator
Model / Ref / Catalog
IRC9LXO2AWQL5
Primary DI / UDI-DI
00841447114635
510(k) Number
FDA Product Code
CAW
GMDN Term
Stationary oxygen concentrator
Device Class
Class II
Regulation Number
868.5440
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K020386)

Other devices from Invacare Corp.

See all devices from Invacare Corp. →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No