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Invacare® Perfecto2V Oxygen Concentrator IRC5PO2VAWL5

by Invacare Corp. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841447114642 UDI-DIDate21 Jul 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

1 recall · FDA

    • Terminated Z-0514-2021 FDA Class II initiated 30 Oct 2020

    Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valve assembly in the concentrator may lead to failure that can result in self-extinguishing fires or cap explosions.

Specification

GUDID

Trade Name
Invacare® Perfecto2V Oxygen Concentrator
Generic Name
Stationary oxygen concentrator
Model / Ref / Catalog
IRC5PO2VAWL5
Primary DI / UDI-DI
00841447114642
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

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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