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 —…
- GMDN category: Nebulizer, non-heated
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.