Device Dossier

Tube, tracheostomy, single use

Device Dossier for Tube, tracheostomy, single use (Tube, tracheostomy, single use, Class IIb, sponsor Smiths Medical). ARTG record, intended purpose,…

Intended purpose

A single use device intended to create a tracheostomy stoma, permit insertion of a tracheostomy tube and the inner cannula. The device contains all necessary components required to undertake a tracheostomy in order to relieve obstructions in the airway and aid ventilation for tracheostomised patients. The device is available in cuffed, uncuffed, fenestrated version, and in a variety of sizes to meet the individual needs of patients.

TGA Public Summary