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SynCardia TAH-t Instructions for Use
SynCardia Systems, Inc.
Page 25
10.0 System Components
The SynCardia TAH-t system is comprised of the following:
•
Implant Kit - Part # 500101 (Sterile)
Contains left artificial ventricle, right artificial ventricle, 2 inflow connectors, 2
outflow connectors, and an ancillary pack with drivelines, inflow pressure test
plug, outflow pressure test plug, locking ties, and 2 de-airing needles (all
sterile). All sterile components are packaged in double aseptic transfer
packages.
•
Surgical Spares Kit - Part # 500177 (Sterile)
Contains inflow connector, outflow connector, drivelines, inflow pressure test
plug, outflow pressure test plug, and locking ties.
•
Circulatory Support System (External Console) – Part # 400207 (Non-sterile)
•
Air Tank - Part # 390004 (Non-sterile)
There should be two complete implant kits, one surgical spares kit, two
circulatory support systems and eight air tanks.