Device Dossier

Nebulizer, non-heated

Device Dossier for Nebulizer, non-heated (Nebulizer, non-heated, Class IIb, sponsor Obex MedTech). ARTG record, intended purpose, GMDN category —…

Intended purpose

This device is intended to be used to aerosolize liquid medication into gases that are delivered directly to the patient for breathing. Its use is indicated when a licensed healthcare professional prescribes or administers medical aerosols to a patient using a small volume nebulizer. The patient population includes Adults, Pediatrics, and Infants that are spontaneously breathing. The product is a single-patient, non-sterile, disposable, intended to be used in a hospital setting.

TGA Public Summary