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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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ProtekDuo - 00814112020418

TandemHeart blood pump kit with 31 Fr veno-venous cannula
CARDIACASSIST, INC.
5720-3118
Not in Commercial Distribution

  • 00814112020418 ()


  • Cardiopulmonary bypass system mounting unit
  • Mobile extracorporeal gas exchange system catheter kit
  • Cardiopulmonary bypass system centrifugal pump

PROTEK Duo - 00814112020173

TandemHeart blood pump kit with veno-venous cannula
CARDIACASSIST, INC.
5190-0020
Not in Commercial Distribution

  • 00814112020173 ()


  • Cardiopulmonary bypass system mounting unit
  • Cardiopulmonary bypass system centrifugal pump
  • Mobile extracorporeal gas exchange system catheter kit

ProtekDuo - 00814112020401

TandemHeart blood pump kit with 29 Fr veno-venous cannula
CARDIACASSIST, INC.
5720-2916
Not in Commercial Distribution

  • 00814112020401 ()


  • Cardiopulmonary bypass system mounting unit
  • Mobile extracorporeal gas exchange system catheter kit
  • Cardiopulmonary bypass system centrifugal pump

Bio30+ System Physio HR - 05056336800260

Ion exchange chromatography column sold with lithium high resolution column, LED monitor, computer, autosampler and Openlab software.
BIOCHROM LIMITED
80-6000-56
In Commercial Distribution

  • 05056336800260 ()


  • Amino acid analyser IVD

Bio30+ System Physio HP - 05056336800222

Ion exchange chromatography analyzer sold with lithium high performance column, LED monitor, computer, autosampler and Openlab software.
BIOCHROM LIMITED
80-6000-53
In Commercial Distribution

  • 05056336800222 ()


  • Amino acid analyser IVD

Medline - 10888277699526

SZ 4, DISP, SOFT, MASK, LARYNGEAL, PVC
MEDLINE INDUSTRIES, INC.
DYND300040S
In Commercial Distribution

  • 20888277699523 ()
  • 10888277699526 ()
DYND300040S

  • Laryngeal mask airway, single-use
  • Oropharyngeal airway, single-use

Medline - 20888277367996

50MM,BLUE,SOFT GUEDEL AIRWAY
MEDLINE INDUSTRIES, INC.
DYNJGUED50
In Commercial Distribution

  • 10888277367999 ()
  • 20888277367996 ()
DYNJGUED50

  • Oropharyngeal airway, single-use
  • Laryngeal mask airway, single-use

Rika Plasma Bottle - 05020583213005

elabeling.terumobct.com
TERUMO BCT, INC.
21300
In Commercial Distribution

  • 35020583213006 ()
  • 05020583213005 ()


  • Apheresis kit

Rika Plasma Separation Set - 05020583212008

elabeling.terumobct.com
TERUMO BCT, INC.
21200
In Commercial Distribution

  • 35020583212009 ()
  • 05020583212008 ()


  • Apheresis kit

ThermoGard XP Surface Start-Up Kit - 00849111076081

The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surface pad. The Surface Start-Up Kit is a closed-loop disposable that is composed of a pre-attached water reservoir, an extension tubing, a pump loop, a heat exchange coil and an air trap assembly. All of these items work with the console to supply cool water to the surface pad to regulate patient core temperature.
Zoll Circulation, Inc.
Surface Start-Up Kit
In Commercial Distribution

  • 00849111076081 ()
8700-000936-01

  • External circulating-fluid core temperature regulation system start kit
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