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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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The occluder head provides a computer-controlled tube occlusion mechanism. The occluder head is controlled via signals received from the occluder module. The occulder head can be detached from the occluder module.
Terumo Cardiovascular Systems Corporation
806455
In Commercial Distribution

  • 00886799000878 ()
806455

  • Cardiopulmonary bypass system, roller type
Cable used to connect the data module to the intended device.
Terumo Cardiovascular Systems Corporation
804982
In Commercial Distribution

  • 00886799000847 ()
804982

  • Cardiopulmonary bypass system mounting unit
Cable used to connect the CDI data module to the intended CDI device.
Terumo Cardiovascular Systems Corporation
804981
In Commercial Distribution

  • 00886799000830 ()
804981

  • Cardiopulmonary bypass system mounting unit
The occluder module serves as the interface between the occluder head and the system. The occluder system is controlled from the CCM, and can be configured to respond to primary pump events.
Terumo Cardiovascular Systems Corporation
803480
In Commercial Distribution

  • 00886799000779 ()
803480

  • Cardiopulmonary bypass system, roller type
The Interface Module for CDI 500 Module provides the interface between the CDI™ 500 Blood Parameter Monitoring System and the APS1. The module communicates the CDI 500 monitor values to the system for display on the CCM.
Terumo Cardiovascular Systems Corporation
803479
In Commercial Distribution

  • 00886799000762 ()
803479

  • Cardiopulmonary bypass system, roller type
The Interface Module for CDI 100 provides the interface between a CDI ™ 100 or CDI™ 100 Saturation/Hematocrit Monitor and the APS1. The module communicates the CDI monitor values to the system for display on the CCM.
Terumo Cardiovascular Systems Corporation
802558
In Commercial Distribution

  • 00886799000755 ()
802558

  • Cardiopulmonary bypass system, roller type
The interface between the temperature sensor and the rest of the system.
Terumo Cardiovascular Systems Corporation
802114
In Commercial Distribution

  • 00886799000748 ()
802114

  • Cardiopulmonary bypass system, roller type
The RS-232 Interface Module provides the interface between the RS-232 protocol data acquistion software and the system. The module outputs system data to the data acquisition software such as Tlink Data management Software.
Terumo Cardiovascular Systems Corporation
802113
In Commercial Distribution

  • 00886799000731 ()
802113

  • Cardiopulmonary bypass system, roller type
The pressure module serves as the interface between up to two pressure transducers and the system. This module monitors signals from the pressure transducers and communicates pressure values, alerts, and alarms to the system.
Terumo Cardiovascular Systems Corporation
802112
In Commercial Distribution

  • 00886799000724 ()
802112

  • Cardiopulmonary bypass system, roller type
The flowmeter module provides the interface between the flow sensor and the system. The module processes the signals necessary to compute fluid flow values. Those flow values are then communicated to the system. Flowmeter values are displayed on the CCM and, if assigned, on a pump's local display.
Terumo Cardiovascular Systems Corporation
802018
In Commercial Distribution

  • 00886799000687 ()
802018

  • Cardiopulmonary bypass system, roller type
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