FDA.reportPublic FDA data

Ventricular prosthesis system, pneumatically-powered

Definition
An assembly of devices intended to function as an artificial replacement for failing heart ventricles (end-stage biventricular failure), typically temporarily prior to heart transplantation. It consists of two implanted pneumatically-powered pumping units, with built-in mechanical heart valves, which replace the excised natural heart ventricles and are connected to the heart atria, aorta, and pulmonary arteries; the prosthesis is driven by an external pneumatic pump connected via percutaneous pneumatic drive-lines entering the patient's chest.
GUDID devices
20
Last updated
2025-06-06 07:30:41

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00858000003145SynCardia Companion Driver CaddySYNCARDIA SYSTEMS, LLC397001-0012025-05-29
00858000003152SynCardia Companion DrivelinesSYNCARDIA SYSTEMS, LLC193002-0012025-05-29
00858000003244SynCardia Freedom® Car ChargerSYNCARDIA SYSTEMS, LLC295053-0012025-04-24
00858000003251SynCardia Freedom® Battery ChargerSYNCARDIA SYSTEMS, LLC295054-0012025-04-24
00858000003268SynCardia Freedom® Power AdaptorSYNCARDIA SYSTEMS, LLC295070-0012025-04-24
00858000003275SynCardia Freedom® Hospital AC Power SupplySYNCARDIA SYSTEMS, LLC295400-0012025-04-24
00858000003282SynCardia Freedom® Home AC Power SupplySYNCARDIA SYSTEMS, LLC295600-0012025-04-24
00858000003299SynCardia Freedom® Battery Charger Set Shipping ContainerSYNCARDIA SYSTEMS, LLC395103-0012025-04-24
00858000003305SynCardia Hand Pump Shipping ContainerSYNCARDIA SYSTEMS, LLC397004-0012025-04-24
00858000003015SynCardia Freedom® Standby Kit Shipping ContainerSYNCARDIA SYSTEMS, LLC595510-0012025-04-23
00858000003022SynCardia Freedom® Discharge Kit Shipping Container SYNCARDIA SYSTEMS, LLC595630-0012025-04-23
00858000003046SynCardia 70cc TAH-t Surgical Spares KitSYNCARDIA SYSTEMS, LLC500177-0012025-04-23
00858000003053SynCardia 50cc TAH-t, ClinicalSYNCARDIA SYSTEMS, LLC570500-0012025-04-23
00858000003091SynCardia 50cc TAH-t Surgical Spares KitSYNCARDIA SYSTEMS, LLC550177-0012025-04-23
00858000003138SynCardia Companion Hospital CartSYNCARDIA SYSTEMS, LLC397003-0012025-04-23
00858000003190SynCardia Companion Battery Shipping ContainerSYNCARDIA SYSTEMS, LLC197603-0012025-04-23
00858000003206SynCardia Companion Driver Shipping ContainerSYNCARDIA SYSTEMS, LLC397002-0012025-04-23
00858000003213SynCardia Companion Hospital Cart Shipping ContainerSYNCARDIA SYSTEMS, LLC397003-0012025-04-23
00858000003220SynCardia Companion AC Input Power CordSYNCARDIA SYSTEMS, LLC197053-0012025-04-23
00858000003237SynCardia Companion Driver Caddy Shipping ContainerSYNCARDIA SYSTEMS, LLC397001-0012025-04-23