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Portex 535070

by ICU Medical, Inc.

Portex 535070 is a Class II device made by ICU Medical, Inc., listed in FDA GUDID since 29 Jul 2015 (UDI-DI 00351688051908), 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 Number00351688051908 UDI-DI Date29 Jul 2015ListedStatusListed 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  • Withdrawn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
Portex
Generic name
Tracheostomy kit, single-use
Model / reference
535070
Primary DI / UDI-DI
00351688051908
FDA product code
JOH
GMDN term
Tracheostomy kit, single-use
Device class
Class II
Regulation number
868.5800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tracheostomy kit, single-use

Similar devices in this category

Other devices filed under Tracheostomy kit, single-use.

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)