Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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No Description
Abiomed, Inc.
AB Portable Power Pack, Packaged
Not in Commercial Distribution

  • 00813502010138 ()


  • Intracardiac circulatory assist axial-pump catheter
No Description
SYNCARDIA SYSTEMS, LLC
197053-001
In Commercial Distribution

  • 00858000003220 ()


  • Ventricular prosthesis system, pneumatically-powered
Cable Set
BOSTON SCIENTIFIC CORPORATION
M004PF61M499D
In Commercial Distribution

  • 00191506052447 ()
M004PF61M499D

  • Electrocardiographic lead set, reusable
  • Electrical-only medical device connection cable, reusable
Battery
EBR Systems, Inc.
3100
In Commercial Distribution

  • 00859244007029 ()


  • Implantable pacemaker battery
System Controller
Thoratec Corporation
106531US
In Commercial Distribution

  • 05415067039446 ()
106531US

  • Implantable ventricular circulatory assist system control unit
System Controller Low Flow 2.0
Thoratec Corporation
106531LF2
In Commercial Distribution

  • 05415067031105 ()
106531LF2

  • Implantable ventricular circulatory assist system control unit
No Description
Thoratec Corporation
100621
In Commercial Distribution

  • 00813024013396 ()
100621

  • Implantable ventricular circulatory assist system control unit
No Description
Thoratec Corporation
10025-2585-000
In Commercial Distribution

  • 00813024013334 ()
10025-2585-000

  • Implantable ventricular circulatory assist system control unit
No Description
Thoratec Corporation
10025-2600-005
In Commercial Distribution

  • 00813024013303 ()
10025-2600-005

  • Implantable ventricular circulatory assist system control unit
System Controller
Thoratec Corporation
106531US
In Commercial Distribution

  • 00813024013235 ()
106531US

  • Implantable ventricular circulatory assist system control unit
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