Device Dossier

Airway, laryngeal, single-use

Device Dossier for Airway, laryngeal, single-use (Airway, laryngeal, single-use, Class IIb, sponsor Paragon Care). ARTG record, intended purpose, GMDN…

Intended purpose

Disposable Video Laryngeal Mask intended as a supraglottic airway management device. While isolating respiratory and esophageal tracts, it provides and maintains an open airway channel and assisted or controlled ventilation during spontaneous breathing. When deemed clinically necessary, intubation can be performed through Airway Tube of the laryngeal mask.