Device Dossier
Breathing circuit, ventilator, single use
Device Dossier for Breathing circuit, ventilator, single use (Breathing circuit, ventilator, single use, Class IIa, sponsor GE Healthcare). ARTG record,…
- GMDN category: Breathing circuit, ventilator, single use
- Sponsor: GE Healthcare
Intended purpose
: A non-sterile assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.