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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, TandemLung Oxygenator, 29 Fr ProtekDuo Veno-Venous cannula and accessories
CARDIACASSIST, INC.
5830-2916
Not in Commercial Distribution

  • 00814112020753 ()


  • Cardiopulmonary bypass system centrifugal pump
  • Extracorporeal membrane oxygenator
  • Cardiopulmonary bypass system mounting unit
  • Vascular dilator, single-use
  • Mobile extracorporeal gas exchange system catheter kit
TandemHeart Blood Pump Kit with 31 Fr Mini Veno-Venous Cannula
CARDIACASSIST, INC.
5720-3631
Not in Commercial Distribution

  • 00814112020548 ()


  • Vascular dilator, single-use
  • Cardiopulmonary bypass system mounting unit
  • Mechanical infusion pump administration set
  • Cardiopulmonary bypass system centrifugal pump
  • Mobile extracorporeal gas exchange system catheter kit
TandemHeart blood pump kit with 31 Fr V-V cannula, TandemLung oxygenator, and accessories
CARDIACASSIST, INC.
5730-3118
Not in Commercial Distribution

  • 00814112020432 ()


  • Mobile extracorporeal gas exchange system catheter kit
  • Cardiopulmonary bypass system centrifugal pump
  • Cardiopulmonary bypass system mounting unit
  • Mechanical infusion pump administration set
  • Extracorporeal membrane oxygenator
TandemHeart blood pump kit with 29 Fr V-V cannula, TandemLung oxygenator, and accessories
CARDIACASSIST, INC.
5730-2916
Not in Commercial Distribution

  • 00814112020425 ()


  • Mobile extracorporeal gas exchange system catheter kit
  • Cardiopulmonary bypass system centrifugal pump
  • Cardiopulmonary bypass system mounting unit
  • Mechanical infusion pump administration set
  • Extracorporeal membrane oxygenator
LifeSPARC blood pump kit with accessories
CARDIACASSIST, INC.
5800-0000
Not in Commercial Distribution

  • 00814112020593 ()


  • Cardiopulmonary bypass system mounting unit
  • Cardiopulmonary bypass system centrifugal pump
TandemHeart Blood Pump Kit with 31 Fr Mini V-V cannula, TandemLung Oxygentor
CARDIACASSIST, INC.
5730-3631
Not in Commercial Distribution

  • 00814112020555 ()


  • Mechanical infusion pump administration set
  • Cardiopulmonary bypass system mounting unit
  • Cardiopulmonary bypass system centrifugal pump
  • Extracorporeal membrane oxygenator
  • Vascular dilator, single-use
  • Mobile extracorporeal gas exchange system catheter kit
LifeSPARC Priming Tray Kit: LIfeSPARC Blood Pump with TandemLung Oxygenator
CARDIACASSIST, INC.
5800-1000
Not in Commercial Distribution

  • 00814112020609 ()


  • Cardiopulmonary bypass system centrifugal pump
  • Extracorporeal membrane oxygenator
PRE-CONNECTED PACK
ST. JUDE MEDICAL, INC.
CMAEK00
In Commercial Distribution

  • 05415067036414 ()
CMAEK00

  • Cardiopulmonary bypass system priming set
  • Cardiopulmonary bypass system centrifugal pump
TandemHeart blood pump kit with 72cm venous and 15Fr arterial cannulae
CARDIACASSIST, INC.
5710-7215
Not in Commercial Distribution

  • 00814112020395 ()


  • Circulatory assist transseptal cannula
  • Cardiopulmonary bypass system centrifugal pump
TandemHeart blood pump kit with 72cm venous and 17Fr arterial cannulae
CARDIACASSIST, INC.
5710-7217
Not in Commercial Distribution

  • 00814112020388 ()


  • Circulatory assist transseptal cannula
  • Cardiopulmonary bypass system centrifugal pump
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