Consulting Wallah › Device Explorer › Catheters & tubes › Tracheostomy tube, reinforced, non-customized, reu
Device Explorer · FDA GUDID · GMDN 63798

Tracheostomy tube, reinforced, non-customized, reusable

An armoured, hollow cylinder that is inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway, typically for a patient with unusual neck mass, however it is not custom-made for a specific patient. It is

US‑registered devices17,943in commercial distribution
Companies1labelers on GUDID
Single‑use35%of device records
Sterile4%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Icu Medical, Inc.17,943100%

Top labelers

CompanyDevicesShare
Icu Medical, Inc.17,943100%

Company = labeler of record on GUDID. 1 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Bivona

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 cuff17,951

GMDN & GCC registration

  • GMDN code 63798 · non‑implantable
  • Single‑use 35% · sterile 4% · 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

No structured size data on the register.

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

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

17,943 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tracheostomy tube, reinforced, non-customized, reusable", from 1 companies. The largest labeler is Icu Medical, Inc. with 100% of records.

Which FDA product codes apply?

JOH (Tube tracheostomy and tube cuff)

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.

How do I get quotes?

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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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