Device Dossier

Bio-Medicus™Adult Cannula Kit - Cannula, arterial

Device Dossier for Bio-Medicus™Adult Cannula Kit - Cannula, arterial (Cannula, arterial, Class III, sponsor Medtronic). ARTG record, intended purpose,…

Intended purpose

Cannulae are used to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriately-sized cannula within the vessel for cardiopulmonary bypass. The Bio-Medicus™ cannulae (18-cm [7.09-in] tip length models) may be used in either the femoral position as an arterial delivery cannula or in the jugular position as a venous return cannula. The product is intended for use up to 6 hours.

Functional description

Adult cannula with insertion set. Sterile, nonpyrogenic, disposable, single use only.

TGA Public Summary