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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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TandemLung LifeSPARC - 00814112020753

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

ProtekDuo - 00814112020548

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

TandemLung - 00814112020432

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

TandemLung - 00814112020425

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 - 00814112020593

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

ProtekDuo - 00814112020555

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 - 00814112020609

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

CentriMag™ - 05415067036414

PRE-CONNECTED PACK
ST. JUDE MEDICAL, INC.
CMAEK00
In Commercial Distribution

  • 05415067036414 ()
CMAEK00

  • Cardiopulmonary bypass system priming set
  • Cardiopulmonary bypass system centrifugal pump

TandemHeart - 00814112020395

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 - 00814112020388

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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