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
Xandar Kardian Korea Inc.
XK300
Not in Commercial Distribution

  • 08809988780001 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
Huxley Medical, Inc.
1000-02
In Commercial Distribution

  • G2331000020 ()


  • Wearable multiple physiological parameter recorder, reusable
No Description
Huxley Medical, Inc.
1000-01
In Commercial Distribution

  • G2331000010 ()


  • Wearable multiple physiological parameter recorder, reusable
No Description
Huxley Medical, Inc.
1000-00
In Commercial Distribution

  • G2331000000 ()


  • Wearable multiple physiological parameter recorder, reusable
No Description
Sleepiz AG
1.0
In Commercial Distribution

  • 07649996477019 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
VIX-A015腔镜电极
In Commercial Distribution

  • 06924274950608 ()


  • Open-surgery electrosurgical electrode, monopolar, single-use
Scale, Digital Home Health Model DHH-10BT 440lb (200kg) x0.2lb (0.1kg) 300mm (L) x 360mm (W) x 8mm (H) includes (2) AAA batteries, tempered glass Includes Bluetooth connectivity compatible with Apple Health and Google Health APP
Rice Lake Weighing Systems, Inc.
DHH-10BT
In Commercial Distribution

  • 00850042373255 ()
201125

  • Stand-on floor scale, electronic
The HindexRV® Monitoring System is a physiological monitoring device that collects and transmits measurements (heart rate, respiration rate and muscle activity) using sensors. The HindexRV® monitoring system monitors the sympathetic and parasympathetic nervous system using accurate recordings of heart rate (HR) from EKG and provides statistical data as well as heart rate variability (HRV) data.
HHS SYSTEMS, INC.
1
In Commercial Distribution

  • 00860001651911 ()
SA7525HHS

  • Multi-purpose invasive/noninvasive electrode kit
  • Psychophysiological biofeedback system
  • Electrocardiographic electrode, single-use
  • Electrocardiograph, professional, single-channel
The HindexRV® Monitoring System is a physiological monitoring device that collects and transmits measurements (heart rate, respiration rate and muscle activity) using sensors. The HindexRV® monitoring system monitors the sympathetic and parasympathetic nervous system using accurate recordings of heart rate (HR) from EKG and provides statistical data as well as heart rate variability (HRV) data.
HHS SYSTEMS, INC.
1
In Commercial Distribution

  • 00860001651904 ()
SA7525HHS

  • Multi-purpose invasive/noninvasive electrode kit
  • Psychophysiological biofeedback system
  • Electrocardiographic electrode, single-use
  • Electrocardiograph, professional, single-channel
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
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