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Device Explorer · FDA GUDID · GMDN 47119

Tracheostomy tube decannulation cap

A device designed to facilitate tracheostomy tube weaning and removal (decannulation), as well as voice restoration, for patients who have been chronic users of a tracheostomy tube. It is a small plastic cover (a cap), typically brightly coloured for easy iden

US‑registered devices96in commercial distribution
Companies5labelers on GUDID
Single‑use49%of device records
Sterile27%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Premier Dental Products Company4042%
Boston Medical Products, Inc.3031%
Teleflex Incorporated2425%
Tracoe Medical Gmbh11%
Icu Medical, Inc.11%

Top labelers

CompanyDevicesShare
Premier Dental Products Company4042%
Boston Medical Products, Inc.3031%
Teleflex Incorporated2425%
Tracoe Medical Gmbh11%
Icu Medical, Inc.11%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

15 mm AdaptorPlug/Ring SetTRACOE modularPremierPortexPremier Decann StopperMontgomery® Safe-T-Tube™ 15 mm AdaptorMontgomery® Safe-T-Tube™ Plug/Ring SetPILLING

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

FDA product codes

CodeNameDevices
BTOTube, Tracheostomy (W/Wo Connector)48
BTRTube, Tracheal (W/Wo Connector)26
BTOTube, tracheostomy (w/wo connector)24
JOHTube tracheostomy and tube cuff2
BTRTube, tracheal (w/wo connector)1

GMDN & GCC registration

  • GMDN code 47119 · non‑implantable
  • Single‑use 49% · sterile 27% · 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 decannulation cap products are registered in the US?

96 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tracheostomy tube decannulation cap", from 5 companies. The largest labeler is Premier Dental Products Company with 42% of records.

Which FDA product codes apply?

BTO (Tube, Tracheostomy (W/Wo Connector)), BTR (Tube, Tracheal (W/Wo Connector)), BTO (Tube, tracheostomy (w/wo connector)), 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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