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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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Programmed USB Flash Drive, System Configuration
Terumo Cardiovascular Systems Corporation
90000143
In Commercial Distribution

  • 00886799002056 ()
90000143

  • Cardiopulmonary bypass system, roller type
Pressure Module Dual Sensor APS
Terumo Cardiovascular Systems Corporation
893607
In Commercial Distribution

  • 00886799001844 ()
893607

  • Cardiopulmonary bypass system, roller type
Temperature Module Dual Sensor APS
Terumo Cardiovascular Systems Corporation
884660
In Commercial Distribution

  • 00886799001837 ()
884660

  • Cardiopulmonary bypass system, roller type
The mounting arm attaches to the APS1 vertically mounting pole and is used as a mount for the Central Control Monitor.
Terumo Cardiovascular Systems Corporation
90000746
In Commercial Distribution

  • 00886799001820 ()
90000746

  • Portable active medical device mount
Central Control Monitor (CCM) combines an embedded computer, a touch screen, and a Graphical User Interface (GUI) to provide a centralized display of system information and onscreen control of all system devices
Terumo Cardiovascular Systems Corporation
890500
In Commercial Distribution

  • 00886799001813 ()
890500

  • Cardiopulmonary bypass system, roller type
Lamp Assembly, LED, APS1
Terumo Cardiovascular Systems Corporation
893479
In Commercial Distribution

  • 00886799001806 ()
893479

  • Fixed examination/treatment room light
Base, for Sarns™ Modular Perfusion System 8000
Terumo Cardiovascular Systems Corporation
16400
In Commercial Distribution

  • 00886799001776 ()
16400

  • Cardiopulmonary bypass system, roller type
Cable assembly, for use with the air bubble detection module and sensor
Terumo Cardiovascular Systems Corporation
822763
In Commercial Distribution

  • 00886799001479 ()
822763

  • Cardiopulmonary bypass system air bubble/fluid level detector
The centrifugal control unit provides the local display and control mechanism for the centrifugal motor and disposable pump and serves as the interface between the centrifugal motor and the rest of the system. The local display indicates the motor speed, flow rate, and safety, status and error messages. The pump can be controlled from either the CCM or from the control knob on the control unit.
Terumo Cardiovascular Systems Corporation
816572
In Commercial Distribution

  • 00886799001387 ()
816572

  • Cardiopulmonary bypass system centrifugal pump drive unit
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 universl tube clamp mechanism accommodates a variety of tubing sizes, including dual tube sets.
Terumo Cardiovascular Systems Corporation
816571
In Commercial Distribution

  • 00886799001370 ()
816571

  • Cardiopulmonary bypass system roller pump
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 universl tube clamp mechanism accommodates a variety of tubing sizes, including dual tube sets.
Terumo Cardiovascular Systems Corporation
816570
In Commercial Distribution

  • 00886799001363 ()
816570

  • Cardiopulmonary bypass system roller pump
Central Control Monitor (CCM) combines an embedded computer, a touch screen, and a Graphical User Interface (GUI) to provide a centralized display of system information and onscreen control of all system devices
Terumo Cardiovascular Systems Corporation
816300
In Commercial Distribution

  • 00886799001325 ()
816300

  • Cardiopulmonary bypass system, roller type
The flow sensor is a non-invasive ultrasonic transducer used to measure fluid velocity.
Terumo Cardiovascular Systems Corporation
806810
In Commercial Distribution

  • 00886799000892 ()
806810

  • Cardiopulmonary bypass system centrifugal pump drive unit
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
806525
In Commercial Distribution

  • 00886799000885 ()
806525

  • Cardiopulmonary bypass system air bubble/fluid level detector
A PC Card contained in one of the CCM card slots that stores a system activity log and is used by authorized service personnel
Terumo Cardiovascular Systems Corporation
803740
In Commercial Distribution

  • 00886799000809 ()
803740

  • Cardiopulmonary bypass system, roller type
The Configuration PC Card is used to backup System 1 Perfusion Configurations. These cards also allow the renaming and deletion of PerfusionConfigurations.
Terumo Cardiovascular Systems Corporation
803739
In Commercial Distribution

  • 00886799000793 ()
803739

  • Cardiopulmonary bypass system, roller type
This kit is provided to store and house miscellaneous items: roller pump knob colored caps, wire markers and tags, spare fasteners, tools that may be needed, and replacement air filter.
Terumo Cardiovascular Systems Corporation
803730
In Commercial Distribution

  • 00886799000786 ()
803730

  • Cardiopulmonary bypass system, roller type
The level detect module serves as the interface between the level sensor and the system. This module monitors level sensors mounted on a hardsheel blood reserviour and communicates any alerts or alarms to the system.
Terumo Cardiovascular Systems Corporation
802111
In Commercial Distribution

  • 00886799000717 ()
802111

  • Cardiopulmonary bypass system air bubble/fluid level detector
The Air Bubble Detect (ABD) module is the interface between an air sensor and the system. The ABD module monitors the air sensor and communicates any alarms to the system.
Terumo Cardiovascular Systems Corporation
802110
In Commercial Distribution

  • 00886799000700 ()
802110

  • Cardiopulmonary bypass system air bubble/fluid level detector
Central Control Monitor (CCM) combines an embedded computer, a touch screen, and a Graphical User Interface (GUI) to provide a centralized display of system information and onscreen control of all system devices.
Terumo Cardiovascular Systems Corporation
802100
In Commercial Distribution

  • 00886799000694 ()
802100

  • Cardiopulmonary bypass system, roller type
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