Device Dossier
Endoscopic insufflation tubing set
Device Dossier for Endoscopic insufflation tubing set (Endoscopic insufflation tubing set, Class IIa, sponsor Device Technologies). ARTG record, intended…
- GMDN category: Endoscopic insufflation tubing set
- Sponsor: Device Technologies
Intended purpose
A collection of sterile flexible tubing intended to be used as a conduit to deliver medical gases [e.g., carbon dioxide (CO2), medical air] from it source to the air/water channel of an endoscope for insufflation during an endoscopic procedure. It includes synthetic polymer tubing and associated connectors; it may also be intended for endoscopic lens drying, or delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.