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Device Explorer · FDA GUDID · GMDN 58705

Tracheostoma protective filter

A non-sterile device designed as a filter for protecting a stomal opening in the windpipe (surgically-created artificial opening between the trachea and the body surface through which the patient can breathe) against harmful external influences. It may also fu

US‑registered devices63in commercial distribution
Companies1labelers on GUDID
Single‑use92%of device records
Sterile0%labelled sterile
Prescription54%Rx‑only share
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Share of device records

Atos Medical Ab63100%

Top labelers

CompanyDevicesShare
Atos Medical Ab63100%

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

Brand names on the register (sample)

Provox Life LP Kit 14 - LT 10/55Provox Life LP Kit 17 - LT 10/55-2HTTPProvox Life LP Kit 16 - LT 10/55-2HSTPProvox Life LP Kit 15 - LT 10/55-2HProvox Life Go HME ExperienceProvox Life Home HME ExperienceTrachPhone (5 pcs)Provox Life Protect HME ExperienceProvox Life Energy HME ExperienceProvox Life Night HME ExperienceProvox Life Day & Night EXP StabilityProvox Life Day & Night EXP SensitiveProvox Life Day & Night Experience PlusProvox Life Day & Night Experience OvalProvox Life Day & Night Experience RoundProvox Life Coming Home USA

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

FDA product codes

CodeNameDevices
BYDCondenser, Heat And Moisture (Artificial Nose)40
OGWTracheostomy Kit17
JOHTube Tracheostomy And Tube Cuff5
EWLProsthesis, Laryngeal (Taub)4
KAEForceps, Ent1

GMDN & GCC registration

  • GMDN code 58705 · non‑implantable
  • Single‑use 92% · sterile 0% · Rx‑only 54% · OTC 46%
  • 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) · 2

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

How many tracheostoma protective filter products are registered in the US?

63 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tracheostoma protective filter", from 1 companies. The largest labeler is Atos Medical Ab with 100% of records.

Which FDA product codes apply?

BYD (Condenser, Heat And Moisture (Artificial Nose)), OGW (Tracheostomy Kit), JOH (Tube Tracheostomy And Tube Cuff), EWL (Prosthesis, Laryngeal (Taub))

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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