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Device Explorer · FDA GUDID · GMDN 63438

Tracheostomy tube neck holder, single-use

A non-sterile, noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not

US‑registered devices179in commercial distribution
Companies20labelers on GUDID
Single‑use99%of device records
Sterile0%labelled sterile
Prescription22%Rx‑only share
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Share of device records

Pepper Medical Inc.4223%
Neotech Products Llc2916%
Marpac, Inc.2112%
Dynarex Corporation1810%
Resp Devices Llc148%
Twin Med, Llc137%
Sunset Healthcare Solutions, Inc.106%
Vbm Medizintechnik Gmbh42%

Top labelers

CompanyDevicesShare
Pepper Medical Inc.4223%
Neotech Products Llc2916%
Marpac, Inc.2112%
Dynarex Corporation1810%
Resp Devices Llc148%
Twin Med, Llc137%
Sunset Healthcare Solutions, Inc.106%
Vbm Medizintechnik Gmbh42%
Mckesson Medical-Surgical Inc.42%
Icu Medical, Inc.42%
Atos Medical Ab32%
Hammer-Plane Inc32%

Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Freevent Neckband, two-piece, largeFreevent Neckband, two-piece, smallProvox TubeHolderCreate Biotechn.a.CARDINAL HEALTH ESSENTIALSStrongholdDr ZeeTrach TieVent TiePedi TieTrachstayTrachguardTwo Piece Tracheostomy Tie Pediatric 2cm x 45.5cTwo Piece Tracheostomy Tie Pediatric 2cm x 35.5cTwo Piece Tracheostomy Tie Pediatric 2cm x 25.5c

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

FDA product codes

CodeNameDevices
CBHDevice, Fixation, Tracheal Tube123
CBHDEVICE, FIXATION, TRACHEAL TUBE48
JAYSupport, Breathing Tube12
JAYSUPPORT, BREATHING TUBE4
BZOSet, Tubing And Support, Ventilator (W Harness)1

GMDN & GCC registration

  • GMDN code 63438 · non‑implantable
  • Single‑use 99% · sterile 0% · Rx‑only 22% · OTC 36%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 13Width (Inch) · 13Length (Centimeter) · 4Length (Millimeter) · 3

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

How many tracheostomy tube neck holder, single-use products are registered in the US?

179 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tracheostomy tube neck holder, single-use", from 20 companies. The largest labeler is Pepper Medical Inc. with 23% of records.

Which FDA product codes apply?

CBH (Device, Fixation, Tracheal Tube), CBH (DEVICE, FIXATION, TRACHEAL TUBE), JAY (Support, Breathing Tube), JAY (SUPPORT, BREATHING TUBE)

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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