Kidney donor-organ preservation/transport perfusion set

This category includes sterile, single-use devices designed to maintain continuous perfusion of a donated kidney during preservation, evaluation, and transport from donor to recipient hospital. The system supports the organ by circulating oxygenated fluid or blood through a closed circuit that mimics physiological conditions, helping to assess viability and reduce ischemic injury prior to transplantation.

Devices in this category are intended for one-time use only and are supplied as part of a complete perfusion system. They include components such as pumps, oxygenators, reservoirs, sensors, cannulae, filters, and tubing sets, all working together to sustain kidney function ex vivo. Regulatory oversight focuses on ensuring sterility, performance, and safety of the entire set as a single-use medical device intended for critical organ support.