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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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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

medilog DARWIN2 U - 07613365003758

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 - 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

RhythmView - 00810591020116

RhythmView Workstation, US
ABBOTT
2000
In Commercial Distribution

  • 00810591020116 ()
2000

  • Cardiac mapping system

RhythmView - 00810591020109

Assembly, Solid State Drive
ABBOTT
USB-SSD
In Commercial Distribution

  • 00810591020109 ()
USB-SSD

  • Cardiac mapping system

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

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

HeartCentrix - 00812345029802

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

  • 00812345029802 ()


  • Patient health record information system application software

iLab Ultrasound Imaging System - 08714729854029

Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
M004EPIL240CARTR0
In Commercial Distribution

  • 08714729854029 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729854012

Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
M004EPIL220CARTR0
In Commercial Distribution

  • 08714729854012 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729854005

Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
M004EPIL100CARTR0
In Commercial Distribution

  • 08714729854005 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729853992

Cart Demo System
BOSTON SCIENTIFIC CORPORATION
M004EPIL240CARTD0
In Commercial Distribution

  • 08714729853992 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729853985

Cart Demo System
BOSTON SCIENTIFIC CORPORATION
M004EPIL220CARTD0
In Commercial Distribution

  • 08714729853985 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729853978

Cart Demo System
BOSTON SCIENTIFIC CORPORATION
M004EPIL100CARTD0
In Commercial Distribution

  • 08714729853978 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729853961

Cart Demo System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240CARTBD0
In Commercial Distribution

  • 08714729853961 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729853954

Cart Demo System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120CARTBD0
In Commercial Distribution

  • 08714729853954 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729853923

Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240CARTB0
In Commercial Distribution

  • 08714729853923 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729853916

Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120C271R0
In Commercial Distribution

  • 08714729853916 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729848967

Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
H749ILAB220CARTR0
In Commercial Distribution

  • 08714729848967 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729848905

Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240INSB0
In Commercial Distribution

  • 08714729848905 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729848899

Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120INSB0
In Commercial Distribution

  • 08714729848899 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729847892

Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120N2710
In Commercial Distribution

  • 08714729847892 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729847885

Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120C2710
In Commercial Distribution

  • 08714729847885 ()


  • Cardiovascular ultrasound imaging system

EndoPATx - 07290109225432

EndoPATx Device
ITAMAR MEDICAL LTD
EndoPATx
In Commercial Distribution

  • 07290109223377 ()
  • 07290109225432 ()
US1650007

  • Cardiovascular-risk peripheral arterial tonometry system

EndoPATx - 07290109225425

EndoPATx Device
ITAMAR MEDICAL LTD
EndoPATx
In Commercial Distribution

  • 07290109225425 ()
  • 07290109223353 ()
AS1650007

  • Cardiovascular-risk peripheral arterial tonometry system

Endo PAT 2000 - 07290109225395

Endo PAT 2000 Device
ITAMAR MEDICAL LTD
Endo PAT 2000
In Commercial Distribution

  • 07290109225388 ()
  • 07290109225395 ()
US1650030

  • Cardiovascular-risk peripheral arterial tonometry system

Endo PAT 2000 - 07290109225371

EndoPAT2000 Device
ITAMAR MEDICAL LTD
Endo PAT 2000
In Commercial Distribution

  • 07290109225364 ()
  • 07290109225371 ()
AS1650030

  • Cardiovascular-risk peripheral arterial tonometry system

Endo PAT 2000 - 07290109225357

Endo PAT 2000 Device
ITAMAR MEDICAL LTD
Endo PAT 2000
In Commercial Distribution

  • 07290109225357 ()
  • 07290109225333 ()
  • 07290109225319 ()
US1650004

  • Cardiovascular-risk peripheral arterial tonometry system

Endo PAT 2000 - 07290109225340

EndoPAT2000 Device
ITAMAR MEDICAL LTD
Endo PAT 2000
In Commercial Distribution

  • 07290109225340 ()
  • 07290109225326 ()
  • 07290109225302 ()
AS1650004

  • Cardiovascular-risk peripheral arterial tonometry system
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