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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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LifeSPARC Blood Pump Kit with 62cm Transseptal Cannula and 15Fr Arterial Cannula
CARDIACASSIST, INC.
5810-6215
Not in Commercial Distribution

  • 00814112020722 ()


  • Cardiopulmonary bypass system mounting unit
  • Cardiopulmonary bypass system centrifugal pump
  • Circulatory assist transseptal cannula
  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
LifeSPARC Blood Pump Kit with 62cm Transseptal Cannula and 17Fr Arterial Cannula
CARDIACASSIST, INC.
5810-6217
Not in Commercial Distribution

  • 00814112020715 ()


  • Cardiopulmonary bypass system mounting unit
  • Cardiopulmonary bypass system centrifugal pump
  • Circulatory assist transseptal cannula
  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
TandemLife Priming Tray Kit: TandemHeart Blood Pump with TandemLung Oxygenator
CARDIACASSIST, INC.
5180-0000
Not in Commercial Distribution

  • 00814112020494 ()


  • Mechanical infusion pump administration set
  • Cardiopulmonary bypass system mounting unit
  • Cardiopulmonary bypass system centrifugal pump
  • Extracorporeal membrane oxygenator
TandemLife blood pump kit with oxygenator and accessories
CARDIACASSIST, INC.
5740-0000
Not in Commercial Distribution

  • 00814112020470 ()


  • Extracorporeal membrane oxygenator
  • Cardiopulmonary bypass system centrifugal pump
  • Cardiopulmonary bypass system mounting unit
  • Mechanical infusion pump administration set
LifeSPARC Blood Pump, TandemLung Oxygenator, 15 Fr Arterial Cannula, 24 Fr Venous Cannnula and accessories
CARDIACASSIST, INC.
5840-2415
Not in Commercial Distribution

  • 00814112020708 ()


  • Cardiopulmonary bypass system centrifugal pump
  • Extracorporeal membrane oxygenator
  • Cardiopulmonary bypass system mounting unit
  • Vascular dilator, single-use
  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
LifeSPARC Blood Pump, TandemLung Oxygenator, 17 Fr Arterial Cannula, 24 Fr Venous Cannula, and accessories
CARDIACASSIST, INC.
5840-2417
Not in Commercial Distribution

  • 00814112020692 ()


  • Cardiopulmonary bypass system centrifugal pump
  • Extracorporeal membrane oxygenator
  • Cardiopulmonary bypass system mounting unit
  • Vascular dilator, single-use
  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
TandemHeart blood pump,TandemLung Oxygenator,15 Fr Arterial,24 Fr Venous Cannnula and accessories
CARDIACASSIST, INC.
5740-2415
Not in Commercial Distribution

  • 00814112020524 ()


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Vascular dilator, single-use
  • Extracorporeal membrane oxygenator
  • Cardiopulmonary bypass system centrifugal pump
  • Cardiopulmonary bypass system mounting unit
  • Mechanical infusion pump administration set
TandemHeart blood pump,TandemLung Oxygenator,17 Fr Arterial 24 Fr Venous Cannula, and accessories
CARDIACASSIST, INC.
5740-2417
Not in Commercial Distribution

  • 00814112020517 ()


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Vascular dilator, single-use
  • Extracorporeal membrane oxygenator
  • Cardiopulmonary bypass system centrifugal pump
  • Cardiopulmonary bypass system mounting unit
  • Mechanical infusion pump administration set
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