Device Dossier
Nebulizing system delivery set, reusable
Device Dossier for Nebulizing system delivery set, reusable (Nebulizing system delivery set, reusable, Class IIb, sponsor Mediplast). ARTG record,…
- GMDN category: Nebulizing system delivery set, reusable
- Sponsor: Mediplast
Intended purpose
A set of devices intended to generate / deliver aerosol for inhalation for the therapy of the lower airways. Together with compressor and with accessories, the set of device forms an inhalation system. When used in home environment, this device set is 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.