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Medex 22-7500

by ICU Medical, Inc.

Medex 22-7500 is a respiratory muscle training mask (FDA Class I; FDA product code ION, Exerciser, Non-Measuring) made by ICU Medical, Inc., listed in FDA GUDID since 18 Dec 2019 (UDI-DI 00788942275006), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00788942275006 UDI-DI Date18 Dec 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Medex
Generic name
Respiratory muscle training mask
Model / reference
22-7500
Primary DI / UDI-DI
00788942275006
FDA product code
ION
GMDN term
Respiratory muscle training mask
Device class
Class I
Regulation number
890.5370
GUDID distribution status
In Commercial Distribution

Related devices

Category: Respiratory muscle training mask

Similar devices

Other devices filed under FDA product code ION (EXERCISER, NON-MEASURING).

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)