A hollow device intended to be used routinely by a patient to prevent the narrowing of a tracheostoma during intermittent use of their tracheostomy or laryngectomy tube. It is a cylindrical synthetic polymer device designed for minimal intrusion beyond the tra
| Company | Devices | Share |
|---|---|---|
| Boston Medical Products, Inc. | 60 | 53% |
| Eon Meditech Private Limited | 20 | 18% |
| Atos Medical Ab | 17 | 15% |
| Icu Medical, Inc. | 16 | 14% |
Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| BTO | Tube, Tracheostomy (W/Wo Connector) | 110 |
| BTR | Tube, Tracheal (W/Wo Connector) | 50 |
| JOH | Tube Tracheostomy And Tube Cuff | 50 |
| KAC | TUBE, LARYNGECTOMY | 42 |
| KAC | Tube, Laryngectomy | 37 |
| BTO | Tube, tracheostomy (w/wo connector) | 16 |
Use these as the dimensions to specify in a tender line.
113 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tracheostoma button", from 4 companies. The largest labeler is Boston Medical Products, Inc. with 53% of records.
BTO (Tube, Tracheostomy (W/Wo Connector)), BTR (Tube, Tracheal (W/Wo Connector)), JOH (Tube Tracheostomy And Tube Cuff), KAC (TUBE, LARYNGECTOMY)
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.