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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 Argos Cardiac Output monitoring device is intended for use on patients above the age of 18. It is intended to be used as a hemodynamic monitor for monitoring cardiac output and its derived parameters on patients in the intensive care unit or the operating room.
RETIA MEDICAL, LLC
FG-001
In Commercial Distribution

  • 00860001506402 ()


  • Noninvasive haemodynamic monitoring system
Hypotension Decision Assist HDA-OR2 is a clinical decision support Software as a Medical Device (SaMD) that is installed upon a medically-rated touch-screen tablet computer. HDA-OR2 connects to a multi-parameter patient monitor supplied by other manufacturers, from which it acquires vital signs data continuously including the arterial blood pressure waveform and cardiovascular-related numeric parameters. HDA-OR2 continually processes this data to display, in graphical charts and numeric format, vital signs data and derived variables including mean arterial pressure (MAP), heart rate, systolic and diastolic blood pressure, cardiac output and systemic vascular resistance. HDA-OR2 compares MAP to user set targets to indicate when MAP is above or below the target range. It allows the user to mark the administration of vasopressors and volume challenges to the MAP trend.
DIRECTED SYSTEMS LIMITED
HDA-OR2
In Commercial Distribution

  • 00860003496718 ()


  • Clinical management support software
Hypotension Decision Assist (HDA) is a clinical decision support Software as a Medical Device (SaMD) that is installed upon a medically-rated touch-screen computer. HDA connects to a multi-parameter patient monitor supplied by other manufacturers, from which it acquires vital signs data continuously including the arterial blood pressure waveform and cardiovascular-related numeric parameters. HDA continually processes this data to display, in graphical charts and numeric format, vital signs data and derived variables including mean arterial pressure (MAP), heart rate, systolic and diastolic blood pressure, cardiac output and systemic vascular resistance. HDA compares MAP to user set targets to indicate when MAP is above or below the target range. It allows the user to mark the administration of vasopressors and volume challenges to the MAP trend.
DIRECTED SYSTEMS LIMITED
HDA-OR1
In Commercial Distribution

  • 00860003496701 ()


  • Clinical management support software
Argos Monitor Power Supply and AC Cord
RETIA MEDICAL, LLC
FG-010
In Commercial Distribution

  • 00860001506495 ()


  • Noninvasive haemodynamic monitoring system
Argos LAN Connectivity Kit
RETIA MEDICAL, LLC
FG-008
In Commercial Distribution

  • 00860001506471 ()


  • Noninvasive haemodynamic monitoring system
Drager Interface Cable (14-pin MDR)
RETIA MEDICAL, LLC
FG-006
In Commercial Distribution

  • 00860001506457 ()


  • Noninvasive haemodynamic monitoring system
Transducer Interface Cable
RETIA MEDICAL, LLC
FG-004
In Commercial Distribution

  • 00860001506433 ()


  • Noninvasive haemodynamic monitoring system
Philips Interface Cable (3.5 mm Stereo Jack)
RETIA MEDICAL, LLC
FG-002
In Commercial Distribution

  • 00860001506419 ()


  • Noninvasive haemodynamic monitoring system
EV1000 POWER ADAPTOR
Edwards Lifesciences LLC
EVPSB110L
In Commercial Distribution

  • 00690103191196 ()

  • Length: 15 Feet
EVPSB110L

  • Electrical mains power cable
EV1000 POWER ADAPTOR
Edwards Lifesciences LLC
EVPSB110
In Commercial Distribution

  • 00690103191172 ()

  • Voltage: 110V
EVPSB110

  • Electrical mains power cable
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