Device Dossier

Novalung kits (XLung kit 230, MiniLung kit 1/4", MiniLung petite) - Cardiopulmonary bypass system tubing set

Device Dossier for Novalung kits (XLung kit 230, MiniLung kit 1/4", MiniLung petite) - Cardiopulmonary bypass system tubing set (Cardiopulmonary bypass…

Intended purpose

The Novalung kit range (XLung, MiniLung, MiniLung petite) is intended for long-term respiratory/cardiopulmonary support through the extracorporeal gas exchange, pumping and thermoregulation of blood in patients with acute respiratory or cardiopulmonary distress or failure

Functional description

The Novalung kit enables extracorporeal blood thermoregulation and gas exchange by diffusion across a gas permeable and plasma tight polymethylpentene membrane lung. The patient’s blood is transported by a non occlusive centrifugal pump head connected to an extracorporeal circuit that directs the flow through the membrane lung and returned to the patient. All device blood contacting surfaces are coated with a stable and biocompatible high molecular weight heparin covalently bound polypeptide.

TGA Public Summary