FDA.reportPublic FDA data

Artificial heart, temporary

Definition
A sterile prosthetic device implanted in the thorax or abdomen that typically consists of an implantable metallic and plastic mechanism that includes one or more pumps working as artificial ventricles to circulate blood, and an electrical or air driven external power unit that is connected to the pumps through transcutaneous electrical wires or pneumatic drive-lines entering the patient's chest. The power unit is attached to the patient and includes a battery and/or a pneumatic console. This device is used mostly as a bridge to heart transplantation.
GUDID devices
29
Last updated
2020-04-29 01:53:06

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00888707000017HVAD® Pump Implant Kit (Enhanced)Heartware Inc.11032014-08-13
00888707000024Driveline Extension CableHeartware Inc.100US2014-08-13
00888707000031HeartWare® Shower BagHeartware Inc.2000US2014-08-13
00888707000048HeartWare® Waist PackHeartware Inc.2050US2014-08-13
00888707000055HeartWare® Shoulder PackHeartware Inc.2060US2014-08-13
00888707000062HVAD Pump Implant KitHeartware Inc.11032014-10-01
00888707000079HeartWare® BatteryHeartware Inc.16502014-08-13
00888707000086HeartWare® Monitor AC AdapterHeartware Inc.1555US2014-08-13
00888707000093HeartWare® Controller AC AdapterHeartware Inc.1425US2014-08-13
00888707000109HeartWare® Controller DC AdapterHeartware Inc.14352014-08-14
00888707000116HeartWare® ControllerHeartware Inc.1403US2014-08-14
00888707000123HeartWare® MonitorHeartware Inc.1520US2014-08-14
00888707000130HeartWare® Battery ChargerHeartware Inc.1600US2014-08-14
00888707000147HVAD® Pump Implant AccessoriesHeartware Inc.11532014-08-14
00888707000154HVAD® Pump Surgical ToolsHeartware Inc.13182014-08-13
00888707000161Alarm AdapterHeartware Inc.14502014-08-14
00888707000178Patient PackHeartware Inc.14752014-08-14
00888707000185HVAD® Pump Surgical ToolsHeartware Inc.13172014-08-14
00888707000192USB Flash DriveHeartware Inc.15602014-08-14
00888707000208Data CableHeartware Inc.15752014-08-14
00888707000215Explant KitHeartware Inc.17502014-08-14
00888707000222HVAD® Pump Outflow GraftHeartware Inc.11252014-08-14
00888707000376HeartWare® BatteryHeartware Inc.16502015-06-24
00858000003008SynCardia temporary Total Artificial Heart SystemSYNCARDIA SYSTEMS, LLC500101-0012015-10-23
00858000003077SynCardia Companion Rechargeable LI-ION BatterySYNCARDIA SYSTEMS, LLC293001-0012015-10-23
00858000003084SynCardia Freedom® Onboard BatterySYNCARDIA SYSTEMS, LLC295025-0012015-10-23
00858000003107SynCardia Companion 2 Driver SYNCARDIA SYSTEMS, LLC397002-0012015-10-23
00858000003114SynCardia Hand PumpSYNCARDIA SYSTEMS, LLC397004-0012015-10-23
00858000003121SynCardia Freedom® DriverSYNCARDIA SYSTEMS, LLC595000-0012015-10-23