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MediChoice UD9003

by Owens & Minor Distribution, Inc.

MediChoice UD9003 is a Class II device made by Owens & Minor Distribution, Inc., cleared under FDA 510(k) K820227 on 23 Feb 1982 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 30885632127629), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

510(k) K820227

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number30885632127629 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK820227 Date23 Feb 1982DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K820227 decided 23 Feb 1982 Active
  • FDA GUDID UDI-DI 30885632127629 listed 21 Sep 2016 Listed

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0721-2019 FDA Class I initiated 5 Sep 2017
    • Terminated Z-0719-2019 FDA Class I initiated 5 Sep 2017
    • Terminated Z-0720-2019 FDA Class I initiated 5 Sep 2017

    Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Timeline

5 dated events

  1. Cleared FDA 510(k) K820227
  2. Listed FDA GUDID 30885632127629
  3. Recall initiated FDA recalls Z-0721-2019
  4. Recall initiated FDA recalls Z-0719-2019
  5. Recall initiated FDA recalls Z-0720-2019

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MediChoice
Generic name
Inhalation therapy saline solution, hypertonic
Model / reference
UD9003
Primary DI / UDI-DI
30885632127629
510(k) Number
FDA product code
CAF
GMDN term
Inhalation therapy saline solution, hypertonic
Device class
Class II
Regulation number
868.5630
GUDID distribution status
In Commercial Distribution

Related devices

Category: Inhalation therapy saline solution, hypertonic

Cleared under the same submission (K820227)

Similar devices

Other devices filed under FDA product code CAF (NEBULIZER (DIRECT PATIENT INTERFACE)).

Other devices from Owens & Minor Distribution, Inc.

See all devices from Owens & Minor Distribution, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)