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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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MUSE - 00840682142809

MUSE NX
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
NX
In Commercial Distribution

  • 00840682142809 ()


  • Cardiology information system application software

GE Client Workstation - 00840682123594

SOFTWARE GE CLIENT WORKSTATION V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123594 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

CardioLab - 00840682119689

ASSY, CARDIOLAB SIMULATOR GE INT USE
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Simulator-Internal
Not in Commercial Distribution

  • 00840682119689 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

PDM Base Station - 00840682119665

ASSY PDM BASE STATION PLUS CO2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Plus
In Commercial Distribution

  • 00840682119665 ()


  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system

CardioLab - 00840682119641

ASSY, CARDIOLAB SIMULATOR
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Simulator
Not in Commercial Distribution

  • 00840682119641 ()


  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system

CAM - 00840682110075

CAM 14
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
14
In Commercial Distribution

  • 00840682110075 ()


  • Electrocardiograph, professional, single-channel

CAM-USB - 00840682109611

No Description
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
INTERFACE A/T V2
In Commercial Distribution

  • 00840682109611 ()


  • Cardiac stress exercise monitoring system

CardioSoft - 00840682105170

CARDIOSOFT V6.73
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V6.73
In Commercial Distribution

  • 00840682105170 ()


  • Electrocardiograph, professional, multichannel

CS - 00840682105156

CS V6.73
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V6.73
Not in Commercial Distribution

  • 00840682105156 ()


  • Electrocardiograph, professional, multichannel

CASE - 00840682105088

CASE V6.7
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V6.7
In Commercial Distribution

  • 00840682105088 ()


  • Electrocardiograph, professional, multichannel

NA - 00840682104104

No Description
GE Healthcare Finland Oy
E-COP-01
In Commercial Distribution

  • 00840682104104 ()


  • Patient monitoring system module, multifunction

NA - 00840682104098

No Description
GE Healthcare Finland Oy
E-COPSv-01
In Commercial Distribution

  • 00840682104098 ()


  • Patient monitoring system module, multifunction

MUSE - 00840682100182

MUSE V9
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v9
In Commercial Distribution

  • 00840682100182 ()


  • Cardiology information system application software

MARS - 00840682100069

MARS V8
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V8
Not in Commercial Distribution

  • 00840682100069 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

VENDYS II - B546VENDYS1

No Description
ENDOTHELIX, INC.
JK-001V
In Commercial Distribution

  • B546VENDYS1 ()


  • Laser Doppler blood flowmeter

Cordiana Dx16 - 07649988821110

DICOM ECG Viewer/Editor
Cordiana Medical Informatics AG
0160100
In Commercial Distribution

  • 07649988821110 ()


  • Cardiology information system application software

Premier Heart MCG Model VH12 - B320VH120

Premier Heart MCG 12 Lead capture hardware.
PREMIER HEART, LLC
VH12
In Commercial Distribution

  • B320VH120 ()


  • Electrocardiograph, professional, multichannel

Premier Heart MCG Analysis API - B320MCGS0

MCG Analysis API (Dedicated Server or Software-as-a-Service)
PREMIER HEART, LLC
MCGS
In Commercial Distribution

  • B320MCGS0 ()


  • Cardiopulmonary physiological parameter analysis software

Premier Heart MCG Analysis Software - B320MCGC0

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 - B320CF190

Premier Heart MCG Field Unit, Model CF19
PREMIER HEART, LLC
CF19
In Commercial Distribution

  • B320CF190 ()
CF19

  • Cardiopulmonary physiological parameter analysis software
  • Electrocardiograph, professional, multichannel

Hokanson - 00817065021532

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

Hokanson - 00817065021525

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

Hokanson - 00817065021518

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

Hokanson - 00817065021174

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

Hokanson - 00817065021167

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

Hokanson - 00817065021150

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

Hokanson - 00817065021143

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

Hokanson - 00817065021136

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

HeartCentrix - 00812345029994

Cardiology Data Management System
MORTARA INSTRUMENT, INC.
11098-002-50
In Commercial Distribution

  • 00812345029994 ()


  • Patient health record information system application software

Pyramis - 00812345029970

Cardiology Data Management System
MORTARA INSTRUMENT, INC.
92601H-004
In Commercial Distribution

  • 00812345029970 ()


  • Patient health record information system application software

HeartCentrix - 00812345029802

Cardiology Data Management System
MORTARA INSTRUMENT, INC.
H50-71
In Commercial Distribution

  • 00812345029802 ()


  • Patient health record information system application software

Vision Express - 00812345027082

Holter Analysis System
MORTARA INSTRUMENT, INC.
BURV53H-5
In Commercial Distribution

  • 00812345027082 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Vision Express - 00812345027075

Holter Analysis System
MORTARA INSTRUMENT, INC.
BURV53H-2
In Commercial Distribution

  • 00812345027075 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Vision Express - 00812345027068

Holter Analysis System
MORTARA INSTRUMENT, INC.
BURV53H-1
In Commercial Distribution

  • 00812345027068 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Vision Express - 00812345027051

Holter Analysis System
MORTARA INSTRUMENT, INC.
BURV53H-0
In Commercial Distribution

  • 00812345027051 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Pyramis - 00812345024784

Cardiology Data Management System
MORTARA INSTRUMENT, INC.
11095-002-61
In Commercial Distribution

  • 00812345024784 ()


  • Patient health record information system application software

RhythmView - 00810591020185

RhythmView Workstation, US, streaming, refurbished
ABBOTT
2002-R
Not in Commercial Distribution

  • 00810591020185 ()
2002-R

  • Cardiac mapping system

RhythmView - 00810591020161

RhythmView Workstation, US, refurbished
ABBOTT
2000-R
In Commercial Distribution

  • 00810591020161 ()
2000-R

  • Cardiac mapping system

RhythmView - 00810591020154

USB Memory Stick
ABBOTT
USB-MEMSTK
In Commercial Distribution

  • 30810591020155 ()
  • 00810591020154 ()
USB-MEMSTK

  • Cardiac mapping system

RhythmView - 00810591020130

RhythmView Workstation, US, Streaming
ABBOTT
2002
Not in Commercial Distribution

  • 00810591020130 ()
2002

  • Cardiac mapping system
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