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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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No Description
Vektor Medical, Inc.
VMDISP2
In Commercial Distribution

  • 00860007954115 ()


  • Cardiac mapping system workstation
The ECGenius™ System is an electrophysiology measurement system and analysis tool used to acquire, filter, digitize, amplify, display, record, and analyze data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart. The PVI Analyzer™ feature is a secondary measure of pulmonary vein isolation and should not replace traditional methods of confirming isolation.
Cathvision ApS
CVT-0069 R3.2
In Commercial Distribution

  • 05745001034009 ()
CVT-0069 R3.2 ECGenius System

  • Cardiac electrophysiology analysis system
No Description
Philips Medical Systems Nederland B.V.
2.1
In Commercial Distribution

  • 00884838070721 ()
453564530681

  • Patient health record information system
No Description
Philips Medical Systems Nederland B.V.
1.5
In Commercial Distribution

  • 00884838070691 ()
453564495001

  • Patient health record information system
No Description
Philips Medical Systems Hsg
B.01.00
In Commercial Distribution

  • 00884838032408 ()


  • Medical equipment clinical data interfacing software
No Description
Philips Medical Systems Hsg
860343
In Commercial Distribution

  • 00884838030299 ()
860343

  • Electrocardiograph, professional, multichannel
Visualization device with FORS technology intended to aid the positioning and navigation of a connected LumiGuide Wire and optionally a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real time of the connected LumiGuide Wire, and of an endovascular catheter, when combined with a LumiGuide 3D Hub.
Philips Medical Systems Nederland B.V.
LumiGuide Equipment
In Commercial Distribution

  • 00884838112087 ()
NCVC933

  • Diagnostic x-ray digital imaging system workstation application software
The AltaTrack 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with an AltaTrack Guidewire and the AltaTrack Equipment.
Philips Medical Systems Nederland B.V.
AltaTrack 3D Hub
In Commercial Distribution

  • 10884838108582 ()
  • 00884838108585 ()

  • Lumen/Inner Diameter: 0.035 Inch
  • Length: 90 Millimeter
AT3DHNW35

  • Luer/Luer linear connector, single-use
Imaging device with FORS technology intended to aid the positioning and navigation of a connected AltaTrack Guidewire and optionally a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real time of the connected AltaTrack Guidewire, and of an endovascular catheter, when combined with an AltaTrack 3D Hub.
Philips Medical Systems Nederland B.V.
AltaTrack equipment
Not in Commercial Distribution

  • 00884838099340 ()
4322 070 2535 X

  • Diagnostic x-ray digital imaging system workstation application software
The KODEX-EPD™ System is indicated for catheter-based cardiac electrophysiological (EP) procedures. The KODEX-EPD™ System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure.
Philips Medical Systems Nederland B.V.
733015
Not in Commercial Distribution

  • 00884838095229 ()


  • Cardiac mapping system application software
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