Device Dossier
Medical gas delivery line filter, endoscopy
Device Dossier for Medical gas delivery line filter, endoscopy (Microbial medical gas filter, single-use, Class IIa, sponsor Obex MedTech). ARTG record,…
- GMDN category: Microbial medical gas filter, single-use
Intended purpose
A non-sterile screening device intended to be installed in a gas delivery line during endoscopy (e.g., sigmoidoscopy) to filter medical gases prior to their entry into the patient (i.e., via the endoscope air/water channel) to reduce patient exposure to bacteria, scale, and other medical gas contaminants whilst preventing patient body fluids from contaminating the endoscopic equipment. It is a small plastic housing containing a bi-directional, hydrophobic filter typically with slip connections; it may include an attached length of tubing. This is a single-use device.