Device Explorer · FDA GUDID · GMDN 12292

Laryngectomy tube

A hollow device intended to maintain tracheostoma patency immediately after laryngectomy to provide an airway for the patient and to prevent tracheostomal stenosis (narrowing) in the months following the procedure. It is a soft plastic or silicone curved/conto

US‑registered devices120in commercial distribution
Companies10labelers on GUDID
Single‑use84%of device records
Sterile84%labelled sterile
Prescription95%Rx‑only share
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Share of device records

Boston Medical Products, Inc.5647%
Eon Meditech Private Limited2420%
Freudenberg Medical, Llc1210%
Covidien Lp108%
Teleflex Incorporated54%
Novo Surgical, Inc.54%
Galemed Corporation43%
Integra Lifesciences Production Corporation22%

Top labelers

CompanyDevicesShare
Boston Medical Products, Inc.5647%
Eon Meditech Private Limited2420%
Freudenberg Medical, Llc1210%
Covidien Lp108%
Teleflex Incorporated54%
Novo Surgical, Inc.54%
Galemed Corporation43%
Integra Lifesciences Production Corporation22%
Bioseal11%
My Medical Store Llc11%

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

Brand names on the register (sample)

Singer Laryngectomy TubeRUSCHInHealth TechnologiesNovo Surgical Inc.InHealth Technologies; Blom-SingerBioseal Inc.ShileyTC Pad 10 mmSil.FlexgalemedIntegra® Miltex®OSSEOUSNovo SurgicalMy Medical

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

FDA product codes

CodeNameDevices
KACTube, Laryngectomy88
JOHTube tracheostomy and tube cuff10
BYDCondenser, Heat And Moisture (Artificial Nose)6
BTRTube, Tracheal (W/Wo Connector)6
BTOTube, Tracheostomy (W/Wo Connector)6
JOHTube Tracheostomy And Tube Cuff6

GMDN & GCC registration

  • GMDN code 12292 · non‑implantable
  • Single‑use 84% · sterile 84% · Rx‑only 95% · 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

Outer Diameter (Millimeter) · 85Lumen/Inner Diameter (Millimeter) · 85Length (Millimeter) · 84

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

No closely related category with 50+ devices.

How many laryngectomy tube products are registered in the US?

120 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Laryngectomy tube", from 10 companies. The largest labeler is Boston Medical Products, Inc. with 47% of records.

Which FDA product codes apply?

KAC (Tube, Laryngectomy), JOH (Tube tracheostomy and tube cuff), BYD (Condenser, Heat And Moisture (Artificial Nose)), BTR (Tube, Tracheal (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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