Device Dossier
Flexible video bronchoscope, single-use
Device Dossier for Flexible video bronchoscope, single-use (Flexible video bronchoscope, single-use, Class IIa, sponsor Emergo). ARTG record, intended…
- GMDN category: Flexible video bronchoscope, single-use
Intended purpose
Intended purpose: The LoopView single use digital flexible bronchoscope is a sterile, single-use, flexible endoscope intended for endoscopic procedures and examination within the airways and tracheobronchial tree. The endoscope is intended to provide visualization via ViewHub video processor. Medical indication: Lung and airway diseases. Intended user: The device is intended to be used by professional. Intended patient population: Adult (including elderly person). Patient selection criteria: patient over 18 years of age. Intended use environment: The endoscope is intended for use in a hospital environment.