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Medex MX7458

by ICU Medical, Inc.

Medex MX7458 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K952160 on 21 Sep 1995 and listed in FDA GUDID since 21 Mar 2017 (UDI-DI 10351688505392), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K952160

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 Number10351688505392 UDI-DI Date21 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK952160 Date21 Sep 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K952160 decided 21 Sep 1995 Active
  • FDA GUDID UDI-DI 10351688505392 listed 21 Mar 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K952160
  2. Listed FDA GUDID 10351688505392

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Medex
Generic name
In-line backflow valve, single-use
Model / reference
MX7458
Primary DI / UDI-DI
10351688505392
510(k) Number
FDA product code
FPA
GMDN term
In-line backflow valve, single-use
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Similar devices

Other devices filed under FDA product code FPA (Set, administration, intravascular).

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)