Device Dossier
Tube, tracheal, jet ventilation
Device Dossier for Tube, tracheal, jet ventilation (Tube, tracheal, jet ventilation, Class IIb, sponsor Getz Healthcare). ARTG record, intended purpose,…
- GMDN category: Tube, tracheal, jet ventilation
Intended purpose
The LaserJet-Catheter is a sterile, single-use, double-lumen orotracheal catheter intended for adult patients ≥ 58 kg who require controlled jet ventilation during microlaryngeal endoscopic interventions, as well as procedures where minimized chest movement is required. The catheter position is defined as "infraglottic.” The LaserJet-Catheter is a medical device designed to be used in combination with jet ventilators of the monsoon product group for the delivery of an oxygen/air mixture including humidification and to provide a lumen for patient monitoring. The device is intended for use exclusively by clinicians trained and experienced in jet ventilation techniques within a professional healthcare environment.