Device Dossier
PARI Nebuliser System - Nebulizer, non-heated
Device Dossier for PARI Nebuliser System - Nebulizer, non-heated (Nebulizer, non-heated, Class IIb, sponsor Mediplast). ARTG record, intended purpose,…
- GMDN category: Nebulizer, non-heated
- Sponsor: Mediplast
Intended purpose
The PARI inhalation system consists of a PARI compressor and PARI accessories. The system is used to treat the lower airways. Aside from the compressor, if used in home environment, the product components are intended for single patient use only (no patient change). In a professional environment, the device can be used with different patients as long as the corresponding hygiene reprocessing measured are complied with. If the patient is not able to use the product safely on their own, then the treatment must be carried out by the responsible person. The device is suitable only for patients who are able to breathe by themselves and are conscious. The frequency and duration of use is determined by professional medical staff according to individual needs of the patient.