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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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Premier Heart MCG Analysis Cluster software, including: - MCG Clinical Client (reference implementation and API) - MCG Webapps/Report Generator - MCG Clinical Database - MCG Analysis Engine
PREMIER HEART, LLC
MCGC
In Commercial Distribution

  • B320MCGC0 ()


  • Cardiopulmonary physiological parameter analysis software
Premier Heart MCG Field Unit, Model CF19
PREMIER HEART, LLC
CF19
In Commercial Distribution

  • B320CF190 ()
CF19

  • Cardiopulmonary physiological parameter analysis software
  • Electrocardiograph, professional, multichannel
ARTERIAL AND VENOUS EXAM, W/DOPPLER SPECTRA SOFTWARE - 220V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, recorded waveforms and blood pressures. Study results are used by the clinician to assess peripheral vascular disease diagnosis in the patient. Includes interface box to connect computer to physiologic instruments and 220V mains.
D.E.HOKANSON, INC.
5.40
In Commercial Distribution

  • 00817065021532 ()
03417

  • Peripheral vascular haemodynamic measurement application software
ARTERIAL AND VENOUS EXAM SOFTWARE - 220 V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, a recorded waveforms and blood pressures. Study results are used by the clinician to assess peripheral vascular disease in the patient. Includes interface box to connect computer to physiologic instruments and 220V mains.
D.E.HOKANSON, INC.
5.40
In Commercial Distribution

  • 00817065021525 ()
03416

  • Peripheral vascular haemodynamic measurement application software
ARTERIAL INFLOW SOFTWARE - 220V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, recorded waveforms waveform calculations. Study results are used by the clinician to assess peripheral vascular function in the patient. Includes interface box to connect computer to physiologic instruments and 220V mains.
D.E.HOKANSON, INC.
5.40
In Commercial Distribution

  • 00817065021518 ()
03415

  • Peripheral vascular haemodynamic measurement application software
SOFTWARE INTERFACE BOX - An electrically-powered hardwired interface between one or multiple physiologic devices and a connected computer with dedicated physiologic software. The interface receives waveform and pressure data and formats the data before sending it to the computer. The interface also receives signals from the computer to activate a connected physiologic device. The device does not store data after it is sent to the computer.
D.E.HOKANSON, INC.
IB4
In Commercial Distribution

  • 00817065021174 ()
00725

  • Medical networking interface unit
SOFTWARWE- DICOM EXTENSION OPTION - Provides capability for storing NIVP3 patient data in a DICOM system.
D.E.HOKANSON, INC.
5.40
In Commercial Distribution

  • 00817065021167 ()
05072

  • Peripheral vascular haemodynamic measurement application software
ARTERIAL AND VENOUS EXAM, W/DOPPLER SPECTRA SOFTWARE - 110V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, recorded waveforms and blood pressures. Study results are used by the clinician to assess peripheral vascular disease diagnosis in the patient. Includes interface box to connect computer to physiologic instruments and 110V mains.
D.E.HOKANSON, INC.
5.40
In Commercial Distribution

  • 00817065021150 ()
03413

  • Peripheral vascular haemodynamic measurement application software
ARTERIAL AND VENOUS EXAM SOFTWARE - 110V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, a recorded waveforms and blood pressures. Study results are used by the clinician to assess peripheral vascular disease in the patient. Includes interface box to connect computer to physiologic instruments and 110V mains.
D.E.HOKANSON, INC.
5.40
In Commercial Distribution

  • 00817065021143 ()
03412

  • Peripheral vascular haemodynamic measurement application software
ARTERIAL INFLOW SOFTWARE - 110V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, recorded waveforms waveform calculations. Study results are used by the clinician to assess peripheral vascular function in the patient. Includes interface box to connect computer to physiologic instruments and 110V mains.
D.E.HOKANSON, INC.
5.40
In Commercial Distribution

  • 00817065021136 ()
03411

  • Peripheral vascular haemodynamic measurement application software
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