Device Dossier

Heat/moisture exchanger, antimicrobial

Device Dossier for Heat/moisture exchanger, antimicrobial (Heat/moisture exchanger, antimicrobial, Class IIa, sponsor Global Life Sciences Solutions).…

Intended purpose

Intended as a highly efficient single use bacterial/viral filter for use at patient end or machine end applications in breathing systems for the protection of patient, staff, equipment and the environment. It is also a heat and moisture exchanger when used in patient end applications. For Patient End Application, the filter is indicated for the prevention of cross infection via breathing systems in anaesthesia. For Machine End Application, the filter is indicated for use on ventilators, water bath humidifiers and other medical gas equipment (e.g. oxygen concentrators, nebulisers) where the connector fittings comply to ISO 5356-1.

TGA Public Summary