Consulting Wallah › Device Explorer › Procedure kits & trays › Tracheostomy kit, single-use
Device Explorer · FDA GUDID · GMDN 14099

Tracheostomy kit, single-use

A collection of sterile surgical instruments, dressings/swabs, syringe, dilators, tracheostomy tubes and other items intended to be used to create a percutaneous opening in the trachea (tracheotomy) for the insertion of a tracheostomy tube to relieve upper air

US‑registered devices447in commercial distribution
Companies11labelers on GUDID
Single‑use99%of device records
Sterile99%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Cook Incorporated14232%
Cardinal Health 200, Llc11225%
Centurion Medical Products Corporation8519%
Icu Medical, Inc.8519%
Teleflex Incorporated82%
Dermapac Inc.51%
Manus Medical, Llc41%
Professional Medical-Surgical Supply, Incorporated20%

Top labelers

CompanyDevicesShare
Cook Incorporated14232%
Cardinal Health 200, Llc11225%
Centurion Medical Products Corporation8519%
Icu Medical, Inc.8519%
Teleflex Incorporated82%
Dermapac Inc.51%
Manus Medical, Llc41%
Professional Medical-Surgical Supply, Incorporated20%
Lsl Industries, Llc20%
Tracoe Medical Gmbh10%
Altitude Technologies Inc.10%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TRACOE experc Dilation SetRUSCHTMM-ETI (Tactical Medical Module - Endotracheal Blue RhinoWeinmannCiaglia Blue Rhino G2Ciaglia Blue RhinoDolphin BTCiagliaProfessional Medical Surgical Supply, Inc. d / bManus Medical, LLCCustom Healthcare Systems Inc.LSL HEALTHCARECenturionCENTURIONPortex

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 cuff225
OGWTracheostomy kit118
LRQTracheostomy and nasal suctioning kit71
BTOTube, tracheostomy (w/wo connector)63
LROGeneral Surgery Tray12
LROGeneral surgery tray5

GMDN & GCC registration

  • GMDN code 14099 · non‑implantable
  • Single‑use 99% · sterile 99% · Rx‑only 98% · 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

Length (Millimeter) · 8Outer Diameter (Millimeter) · 3Weight (Gram) · 2

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

How many tracheostomy kit, single-use products are registered in the US?

447 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tracheostomy kit, single-use", from 11 companies. The largest labeler is Cook Incorporated with 32% of records.

Which FDA product codes apply?

JOH (Tube tracheostomy and tube cuff), OGW (Tracheostomy kit), LRQ (Tracheostomy and nasal suctioning kit), 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.

How do I get quotes?

Add tracheostomy kit, single-use to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

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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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