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Device Explorer · FDA GUDID · GMDN 36071

Tracheostomy tube speech valve

A device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the pa

US‑registered devices68in commercial distribution
Companies8labelers on GUDID
Single‑use28%of device records
Sterile32%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Boston Medical Products, Inc.1725%
Freudenberg Medical, Llc1319%
Atos Medical Ab1218%
Fogless International Ab710%
Covidien Lp69%
Passy-Muir, Inc.69%
Tracoe Medical Gmbh57%
Airway Company, The23%

Top labelers

CompanyDevicesShare
Boston Medical Products, Inc.1725%
Freudenberg Medical, Llc1319%
Atos Medical Ab1218%
Fogless International Ab710%
Covidien Lp69%
Passy-Muir, Inc.69%
Tracoe Medical Gmbh57%
Airway Company, The23%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SPIROFreevent DualCare Speaking Valve BlueFreevent DualCare Speaking ValveFreevent DualCare Set 22Freevent DualCare Set 15Provox FreeHands FlexiVoice XtraStrongProvox FreeHands FlexiVoice Arch (5 pcs)Provox FreeHands FlexiVoice StrongProvox FreeHands FlexiVoice MediumProvox FreeHands FlexiVoice LightProvox FreeHands FlexiVoice SetProvox FreeHands FlexiVoice Set PlusFreevent Connection strapMontgomery® Cannula Speaking ValveMontgomery® VENTRACH™ Speaking ValveMontgomery® Tracheostomy Speaking Valve

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 Cuff43
EWLProsthesis, Laryngeal (Taub)31
JOHTube tracheostomy and tube cuff7
BTOTube, tracheostomy (w/wo connector)6
BYDCondenser, Heat And Moisture (Artificial Nose)2
CBHDevice, Fixation, Tracheal Tube1

GMDN & GCC registration

  • GMDN code 36071 · non‑implantable
  • Single‑use 28% · sterile 32% · Rx‑only 97% · OTC 3%
  • 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) · 7

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

How many tracheostomy tube speech valve products are registered in the US?

68 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tracheostomy tube speech valve", from 8 companies. The largest labeler is Boston Medical Products, Inc. with 25% of records.

Which FDA product codes apply?

JOH (Tube Tracheostomy And Tube Cuff), EWL (Prosthesis, Laryngeal (Taub)), 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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