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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RemLogic 3.3.2 Installation CD ENU
Embla Systems Ltd
012001
In Commercial Distribution

  • 00382830043441 ()


  • Sleep disorder interpretive software
Stethee Pro Central Web Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000055 ()


  • Phonocardiograph
  • Stethoscope application software
Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000048 ()


  • Phonocardiograph
  • Stethoscope application software
Stethee Pro Mobile Android Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000031 ()


  • Phonocardiograph
  • Stethoscope application software
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - I3 = Resting-ECG Measurement and MEANS Analysis ECG Measurements & Expert System, The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW I3
In Commercial Distribution

  • 07290110255411 ()
HASP-SW-K-I3-01

  • Cardiovascular risk evaluation interpretive software
  • Cardiopulmonary stress exercise monitoring system computer
  • Patient-administration information system application software
HLA Fusion Software for clinical diagnostics features analysis modules for One Lambda’s IVD products such as FlowPRA®, LABScreen®, LABType®, LCT™, Micro SSP™ and more.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022571 ()
FUSPGR

  • HLA class I & II antibody screening IVD, kit, multiplex
  • HLA class I & II antigen tissue typing IVD, kit, multiplex
LCD Stand (when mounting 2 LCD displays on the KD-030A)
NIHON KOHDEN AMERICA, INC.
KH-122A
In Commercial Distribution

  • 00841983100925 ()
KH-122A

  • Instrument trolley
LCD Stand (when mounting 2 LCD displays on the KD-030A)
NIHON KOHDEN CORPORATION
KH-122A
In Commercial Distribution

  • 04931921112915 ()
KH-122A

  • Instrument trolley
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools - 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 S2-I2
In Commercial Distribution

  • 07290110255022 ()
HASP-SW-K-S2I2-01

  • Patient-administration information system application software
  • Cardiovascular risk evaluation interpretive software
  • Cardiopulmonary stress exercise monitoring system computer
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools - I3 = Resting-ECG Measurement and Interpretation MEANS (Uni. of Rotterdam, NL) - D1 = Norav ECG Management System NEMS The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I3-D1
In Commercial Distribution

  • 07290110252816 ()
HASP-SW-K-S2I3D1-01

  • Cardiovascular risk evaluation interpretive software
  • Cardiopulmonary stress exercise monitoring system computer
  • Patient-administration information system application software
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