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

  • 00840682123532 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
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
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
ASSY, CARDIOLAB SIMULATOR
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Simulator
Not in Commercial Distribution

  • 00840682119641 ()


  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system
CAM 14
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
14
In Commercial Distribution

  • 00840682110075 ()


  • Electrocardiograph, professional, single-channel
No Description
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
INTERFACE V2
In Commercial Distribution

  • 00840682109772 ()


  • Cardiac stress exercise monitoring system
No Description
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
INTERFACE A/T V2
In Commercial Distribution

  • 00840682109611 ()


  • Cardiac stress exercise monitoring system
CV WEB 3.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
3
Not in Commercial Distribution

  • 00840682107921 ()


  • Cardiology information system application software
CARDIOSOFT V6.73
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V6.73
In Commercial Distribution

  • 00840682105170 ()


  • Electrocardiograph, professional, multichannel
CS V6.73
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V6.73
Not in Commercial Distribution

  • 00840682105156 ()


  • Electrocardiograph, professional, multichannel
Upgrade Kit MLCL V7.1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
BT21
Not in Commercial Distribution

  • 00840682188968 ()


  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system
MD ACUTE VIRTUAL COLLABORATOR NOTIFY ME 1.0
GE HEALTHCARE
NotifyMe V1.0
Not in Commercial Distribution

  • 00840682152754 ()


  • Patient health record information system
Software Medical Device GE Client Software V7.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
A1
Not in Commercial Distribution

  • 00840682145763 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
Software Medical Device INW V7.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
A1
Not in Commercial Distribution

  • 00840682145756 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
MUSE NX
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
NX
In Commercial Distribution

  • 00840682142809 ()


  • Cardiology information system application software
CASE V6.7
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V6.7
In Commercial Distribution

  • 00840682105088 ()


  • Electrocardiograph, professional, multichannel
CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
CARDIO CALM SRL
4
In Commercial Distribution

  • B972CCZ12050482080 ()
CCZ1205048208

  • Electrocardiographic long-term ambulatory recording analyser application software
CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
CARDIO CALM SRL
4
In Commercial Distribution

  • B972CCZ12050482050 ()
CCZ1205048205

  • Electrocardiographic long-term ambulatory recording analyser application software
CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
CARDIO CALM SRL
4
In Commercial Distribution

  • B972CCZ12050482030 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
No Description
Implicity Inc.
V1.1.4
In Commercial Distribution

  • 03770025266008 ()
IM007

  • Cardiology information system application software
Premier Heart MCG 12 Lead capture hardware.
PREMIER HEART, LLC
VH12
In Commercial Distribution

  • B320VH120 ()


  • Electrocardiograph, professional, multichannel
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 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
No Description
ENDOTHELIX, INC.
JK-001V
In Commercial Distribution

  • B546VENDYS1 ()


  • Laser Doppler blood flowmeter
DICOM ECG Viewer/Editor
Cordiana Medical Informatics AG
0160100
In Commercial Distribution

  • 07649988821110 ()


  • Cardiology information system application software
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
The medilog® DARWIN2 U Holter Analysis is intended for the replay and analysis of ECG data pre-recorded on medilog series ambulatory recorders.
Schiller AG
0.282200
In Commercial Distribution

  • 07613365003758 ()
0.282200

  • Electrocardiographic long-term ambulatory recording analyser application software
RhythmView Workstation, US, streaming, refurbished
ABBOTT
2002-R
Not in Commercial Distribution

  • 00810591020185 ()
2002-R

  • Cardiac mapping system
RhythmView Workstation, US, refurbished
ABBOTT
2000-R
In Commercial Distribution

  • 00810591020161 ()
2000-R

  • Cardiac mapping system
USB Memory Stick
ABBOTT
USB-MEMSTK
In Commercial Distribution

  • 30810591020155 ()
  • 00810591020154 ()
USB-MEMSTK

  • Cardiac mapping system
RhythmView Workstation, US, Streaming
ABBOTT
2002
Not in Commercial Distribution

  • 00810591020130 ()
2002

  • Cardiac mapping system
RhythmView Workstation, US
ABBOTT
2000
In Commercial Distribution

  • 00810591020116 ()
2000

  • Cardiac mapping system
Assembly, Solid State Drive
ABBOTT
USB-SSD
In Commercial Distribution

  • 00810591020109 ()
USB-SSD

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

  • 00812345029994 ()


  • Patient health record information system application software
Cardiology Data Management System
MORTARA INSTRUMENT, INC.
92601H-004
In Commercial Distribution

  • 00812345029970 ()


  • Patient health record information system application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
BURV53H-5
In Commercial Distribution

  • 00812345027082 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
BURV53H-2
In Commercial Distribution

  • 00812345027075 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
BURV53H-1
In Commercial Distribution

  • 00812345027068 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
BURV53H-0
In Commercial Distribution

  • 00812345027051 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Cardiology Data Management System
MORTARA INSTRUMENT, INC.
11095-002-61
In Commercial Distribution

  • 00812345024784 ()


  • Patient health record information system application software
Cardiology Data Management System
MORTARA INSTRUMENT, INC.
H50-71
In Commercial Distribution

  • 00812345029802 ()


  • Patient health record information system application software
Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
M004EPIL240CARTR0
In Commercial Distribution

  • 08714729854029 ()


  • Cardiovascular ultrasound imaging system
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