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Saros Oxygen Concentrator 9400-SEQ

by Caire Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM7669400SEQ0 UDI-DIDate1 Jul 2015ListedStatusListed 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  • Withdrawn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-0248-2020 FDA Class II initiated 16 Sep 2019

    There is an electronics control issue that causes the unit to not power on with battery power only.

Specification

GUDID

Trade Name
Saros Oxygen Concentrator
Generic Name
Mobile/portable oxygen concentrator
Model / Reference
9400-SEQ
Primary DI / UDI-DI
M7669400SEQ0
510(k) Number
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

Cleared under the same submission (K083163)

Other devices from Caire Inc.

See all devices from Caire Inc. →

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