Consulting Wallah › Device Explorer › Catheters & tubes › Tracheostomy tube, non-reinforced, non-customized,
Device Explorer · FDA GUDID · GMDN 35404

Tracheostomy tube, non-reinforced, non-customized, single-use

A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of

US‑registered devices2,276in commercial distribution
Companies10labelers on GUDID
Single‑use70%of device records
Sterile59%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Icu Medical, Inc.89139%
Tracoe Medical Gmbh55424%
Covidien Lp39317%
Hood, E Benson Laboratories Inc30713%
Pulmodyne Inc502%
Well Lead Medical Co.,Ltd362%
Forsure Medical Products Llc201%
Technical Products Inc161%

Top labelers

CompanyDevicesShare
Icu Medical, Inc.89139%
Tracoe Medical Gmbh55424%
Covidien Lp39317%
Hood, E Benson Laboratories Inc30713%
Pulmodyne Inc502%
Well Lead Medical Co.,Ltd362%
Forsure Medical Products Llc201%
Technical Products Inc161%
Venner Medical (Singapore) Pte. Ltd.60%
Cook Incorporated30%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Well Lead Tracheostomy TubeTRACOE twistTRACOE miniTRACOE silcosoftTRACOE twist plusTRACOE® varioTRACOE varioBlomY-Stent with Tracheal Posts with 1mm Wall ThicknRadiopaque Hour Glass Stent with PostsRadiopaque Bronchial Stent with PostsRadiopaque Tracheal Stent with PostsHood Speaking ValveRadiopaque Laryngeal Umbrella KeelLaryngeal Umbrella KeelEliachar Laryngeal Stent

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
JOHTube tracheostomy and tube cuff1,287
BTOTube, tracheostomy (w/wo connector)1,186
JOHTube Tracheostomy And Tube Cuff357
BTOTube, Tracheostomy (W/Wo Connector)297
NWAProsthesis, Tracheal, Preformed/Molded141
FWNProsthesis, Larynx (Stents And Keels)18

GMDN & GCC registration

  • GMDN code 35404 · non‑implantable
  • Single‑use 70% · sterile 59% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Lumen/Inner Diameter (Millimeter) · 1,521Length (Millimeter) · 252Outer Diameter (Millimeter) · 125Angle (degree) · 122Circumference (Millimeter) · 5Height (Millimeter) · 1

Use these as the dimensions to specify in a tender line.

How many tracheostomy tube, non-reinforced, non-customized, single-use products are registered in the US?

2,276 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tracheostomy tube, non-reinforced, non-customized, single-use", from 10 companies. The largest labeler is Icu Medical, Inc. with 39% of records.

Which FDA product codes apply?

JOH (Tube tracheostomy and tube cuff), BTO (Tube, tracheostomy (w/wo connector)), JOH (Tube Tracheostomy And Tube Cuff), BTO (Tube, Tracheostomy (W/Wo Connector))

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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