Device Dossier

Gas sampling line set

Device Dossier for Gas sampling line set (Gas sampling line set, Class IIa, sponsor GE Healthcare). ARTG record, intended purpose, GMDN category —…

Intended purpose

This collection of devices assembled as a disposable set is intended to be used as an interface between a respiratory device in direct contact with a patient (e.g., a breathing circuit) and a measuring instrument (e.g., a carbon dioxide (C02) or multi-gas analyser). The set is installed between the two devices to serve as a conduit for sampling the patient's expired gas for analysis (e.g., end-tidal carbon dioxide (EtCO2) concentration). It may include a membrane to filter pathogenic bacteria and possibly moisture from the sample, to minimize the risk of cross-infection and potential damage to the measuring instrument. This is a single-use device.

TGA Public Summary