Device Dossier
Inspiratory/expiratory limb respiratory tubing
Device Dossier for Inspiratory/expiratory limb respiratory tubing (Inspiratory/expiratory limb respiratory tubing, Class IIa, sponsor Parker Healthcare).…
- GMDN category: Inspiratory/expiratory limb respiratory tubing
Intended purpose
Smooth-Bor Plastics air supply tubing is intended to assist with patient breathing while sleeping, for the purpose of treating Obstructive Sleep Apnea (OSA). The tubing is used as a component in Continuous Positive Airway Pressure (CPAP) devices used on adult patients at home or in the sleep lab. The product is supplied in non-sterile condition and intended to be used as a replacement device.