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Mobi AMER1 35001

by Inova Labs, Inc. GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08582530041149 UDI-DIDate26 Apr 2018ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Mobi AMER1
Generic Name
Stationary oxygen concentrator
Model / Ref / Catalog
35001
Primary DI / UDI-DI
08582530041149
FDA Product Code
CAW
GMDN Term
Stationary oxygen concentrator
Device Class
Class II
Regulation Number
868.5440
GUDID distribution status
Not in Commercial Distribution

Other devices from Inova Labs, Inc.

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • 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
  • Expiration Date: No