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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Cardiology Information System Workstation
MORTARA INSTRUMENT, INC.
MDLTYMGR-5AC-XXXXA
In Commercial Distribution

  • 00817655022413 ()


  • Cardiac stress exercise monitoring system
  • Electrocardiograph, professional, multichannel
  • Electrocardiographic long-term ambulatory recording analyser application software
Cardiology Information System Workstation
MORTARA INSTRUMENT, INC.
MDLTYMGR-5AC-DXXXB
In Commercial Distribution

  • 00817655022390 ()


  • Cardiac stress exercise monitoring system
  • Electrocardiograph, professional, multichannel
  • Electrocardiographic long-term ambulatory recording analyser application software
Cardiology Information System Workstation
MORTARA INSTRUMENT, INC.
MDLTYMGR-5AC-DXXXA
In Commercial Distribution

  • 00817655022383 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
  • Electrocardiograph, professional, multichannel
  • Cardiac stress exercise monitoring system
Cardiology Information System Workstation
MORTARA INSTRUMENT, INC.
MDLTYMGR-5AC-CXXXX
In Commercial Distribution

  • 00817655022376 ()


  • Cardiac stress exercise monitoring system
  • Electrocardiograph, professional, multichannel
  • Electrocardiographic long-term ambulatory recording analyser application software
Cardiology Information System Workstation
MORTARA INSTRUMENT, INC.
MDLTYMGR-5AC-CXXXA
In Commercial Distribution

  • 00817655022369 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
  • Electrocardiograph, professional, multichannel
  • Cardiac stress exercise monitoring system
Cardiology Information System Workstation
MORTARA INSTRUMENT, INC.
SCRIBEWS-5AC-XXXXX
In Commercial Distribution

  • 00817655020587 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
  • Electrocardiograph, professional, multichannel
  • Cardiac stress exercise monitoring system
The Insight Infrared Video Goggles are designed to be used by clinicians to visualize and record patient eye movements. The goggles will be placed on the patient’s head with the cameras in front of the patient’s eyes. The infrared cameras transmit video of the eye movements to a compatible computer screen for display. The computer uses an off-the-shelf video software Open Broadcaster Software (OBS) to allow viewing and recording of the cameras.
Vestibular First, LLC
Insight Infrared Video Goggles
In Commercial Distribution

  • 10860002280704 ()
  • 00860002280707 ()


  • Vision/eye movement analysis system
Total Cholesterol Strips
KPI HEALTHCARE, INC.
CURO L5 Total Cholesterol Strips
In Commercial Distribution

  • 00860394001256 ()
  • 00860394001218 ()


  • Glucose/ketone/lipid monitoring system IVD, home-use
  • Multiple physiological parameter spot-check system analyser
  • Glucose monitoring system IVD, point-of-care
  • Glucose analyser IVD, point-of-care
  • Glucose analyser IVD, laboratory, automated/semi-automated
  • Glucose analyser IVD, laboratory, manual
  • Glucose analyser IVD, laboratory, automated
  • Glucose analyser IVD, home-use
  • Blood glucose/blood pressure monitoring system, point-of-care
  • Glucose monitoring system IVD, home-use
  • Blood glucose/blood pressure monitoring system, home-use
  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
CURO L5 Cholesterol and Glucose measuring system
KPI HEALTHCARE, INC.
CURO L5 CURO L5
In Commercial Distribution

  • 00860394001225 ()


  • Multiple physiological parameter spot-check system analyser
  • Glucose/ketone/lipid monitoring system IVD, home-use
  • Glucose monitoring system IVD, point-of-care
  • Glucose analyser IVD, point-of-care
  • Glucose analyser IVD, laboratory, automated/semi-automated
  • Glucose analyser IVD, laboratory, manual
  • Glucose analyser IVD, laboratory, automated
  • Glucose analyser IVD, home-use
  • Blood glucose/blood pressure monitoring system, point-of-care
  • Glucose monitoring system IVD, home-use
  • Blood glucose/blood pressure monitoring system, home-use
  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
CURO L5 Glucose Strip
KPI HEALTHCARE, INC.
Curo L5
In Commercial Distribution

  • 00850006113064 ()
  • 00850006113057 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
  • Blood glucose/blood pressure monitoring system, home-use
  • Glucose monitoring system IVD, home-use
  • Blood glucose/blood pressure monitoring system, point-of-care
  • Glucose analyser IVD, home-use
  • Glucose analyser IVD, laboratory, automated
  • Glucose analyser IVD, laboratory, manual
  • Glucose analyser IVD, laboratory, automated/semi-automated
  • Glucose analyser IVD, point-of-care
  • Glucose monitoring system IVD, point-of-care
  • Glucose/ketone/lipid monitoring system IVD, home-use
  • Multiple physiological parameter spot-check system analyser
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