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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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System base using a 100V-120V, 15A (circuit breaker), 50/60 Hz (20A power source required) power source
Terumo Cardiovascular Systems Corporation
801763
In Commercial Distribution

  • 00886799000656 ()
801763

  • Cardiopulmonary bypass system, roller type
The electronic gas blender is an optional module that integrates into the APS1 chassis. It accepts inputs of medical grade oxygen and air, or oxygen and 95/5 (a blend of 95% oxygen and 5% carbon dioxide), and allows the ser to control and regulate the gas output to an oxygenator. A built-in oxygen analyzer measures the oxygen content of the blended gas and provides the information to the system for display on the CCM.
Terumo Cardiovascular Systems Corporation
801188
In Commercial Distribution

  • 00886799000588 ()
801188

  • Cardiopulmonary bypass system gas control unit
The centrifugal control unit provides the local display and control mechanism for the centrifugal pump and serves as the interface between the centrifugal motor and the rest of the heart-lung system.
Terumo Cardiovascular Systems Corporation
801046
In Commercial Distribution

  • 00886799000557 ()
801046

  • Cardiopulmonary bypass system centrifugal pump drive unit
Roller Pump (6" Blue). The large roller pump is a peristaltic pump with a 6 inch (15 cm) raceway that can be used for arterial, cardioplegia, vent, and suction applications. A universal tub clamp mechanism accommodates a variety of tubing sizes, including dual tube sets.
Terumo Cardiovascular Systems Corporation
801041
In Commercial Distribution

  • 00886799000540 ()
801041

  • Cardiopulmonary bypass system roller pump
Roller Pump (4" Blue). The small roller pump is a peristaltic pump with a 4 inch (10 cm) raceway that can be used for arterial, cardioplegia, vent, and suction applications. A universal tub clamp mechanism accommodates a variety of tubing sizes, including dual tube sets.
Terumo Cardiovascular Systems Corporation
801040
In Commercial Distribution

  • 00886799000533 ()
801040

  • Cardiopulmonary bypass system roller pump
Roller pump hand cranks used to rotate the roller pump occlusion mechanism during an electrical power failure. These hand cranks can be used on either the large 6" or the small 4" roller pumps.
Terumo Cardiovascular Systems Corporation
801016
In Commercial Distribution

  • 00886799000526 ()
801016

  • Cardiopulmonary bypass system, roller type
Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir.
Terumo Cardiovascular Systems Corporation
217390
In Commercial Distribution

  • 00886799000519 ()
217390

  • Cardiopulmonary bypass system air bubble/fluid level detector
The air sensor is a non-invasive, ultrasonic sensor that can detect air bubbles in the perfusion circuit. This is the 3/8"x3/32" sensor.
Terumo Cardiovascular Systems Corporation
201380
In Commercial Distribution

  • 00886799000502 ()
201380

  • Cardiopulmonary bypass system air bubble/fluid level detector
The level sensor is an ultrasonic transducer that is mounted on a hardshell blood reservoir and detects the presence or absence of blood or prime solution at the point of detection. Red.
Terumo Cardiovascular Systems Corporation
195274
In Commercial Distribution

  • 00886799000496 ()
195274

  • Cardiopulmonary bypass system air bubble/fluid level detector
The level sensor is an ultrasonic transducer that is mounted on a hardshell blood reservoir and detects the presence or absence of blood or prime solution at the point of detection. Yellow.
Terumo Cardiovascular Systems Corporation
195215
In Commercial Distribution

  • 00886799000489 ()
195215

  • Cardiopulmonary bypass system air bubble/fluid level detector
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