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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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72TB server for use with the Genius™ Digital Diagnostics System for short term digital storage.
Hologic, Inc.
INFORMATION MANAGEMENT SYSTEM, LARGE
In Commercial Distribution

  • 15420045513976 ()
ASY-14451

  • Microscope slide digital imaging scanner IVD
  • Laboratory instrument/analyser application software IVD
32TB server for use with the Genius™ Digital Diagnostics System for short term digital storage.
Hologic, Inc.
INFORMATION MANAGEMENT SYSTEM, BASE
In Commercial Distribution

  • 15420045513921 ()
ASY-14305

  • Laboratory instrument/analyser application software IVD
  • Microscope slide digital imaging scanner IVD
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Upgrade from SOFT-NH300-1 to SOFT-NH301-4,Kit The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH300 DL-Rv to 301
In Commercial Distribution

  • 07290110252694 ()
HASP-SW-KNH300-1-UP-1

  • Electrocardiographic long-term ambulatory recording analyser
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - I2 = Resting-ECG Measurement and Advanced Interpretation The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW I2
In Commercial Distribution

  • 07290110252632 ()
HASP-SW-K-I2-01

  • Patient-administration information system application software
  • Cardiopulmonary stress exercise monitoring system computer
  • Cardiovascular risk evaluation interpretive software
Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure. This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity.
Eko Devices, Inc.
v7.x
In Commercial Distribution

  • 00850010298146 ()
ELEFT

  • Cardiopulmonary physiological parameter analysis software
No Description
Magstim, Inc.
6150036
In Commercial Distribution

  • 00850033571028 ()


  • Electroencephalograph
No Description
Sugarmate, LLC
1008182
In Commercial Distribution

  • 00850018992626 ()


  • Self-care monitoring/reporting software
No Description
Sugarmate, LLC
1008181
In Commercial Distribution

  • 00850018992619 ()


  • Self-care monitoring/reporting software
No Description
Sugarmate, LLC
1008180
In Commercial Distribution

  • 00850018992602 ()


  • Self-care monitoring/reporting software
No Description
Sugarmate, LLC
1007228
In Commercial Distribution

  • 00850018992435 ()


  • Self-care monitoring/reporting software
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