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 —…
- GMDN category: Gas sampling line set
- Sponsor: GE Healthcare
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.