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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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Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) French
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(FRE)
In Commercial Distribution

  • 00850015266942 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system
Universal Strip Sensor Kit
ADVANCED BRAIN MONITORING, INC.
XS30-4302
In Commercial Distribution

  • 00850015266935 ()


  • Patient monitoring system module, electroencephalographic
Sensor Harness Adapter Kit
ADVANCED BRAIN MONITORING, INC.
XS30-4206
In Commercial Distribution

  • 00850015266928 ()


  • Patient monitoring system module, electroencephalographic
External Battery Event Marker Cable Kit
ADVANCED BRAIN MONITORING, INC.
UN03-5206
In Commercial Distribution

  • 00850015266911 ()


  • Electrical-only medical device connection cable, reusable
Event Marker Kit
ADVANCED BRAIN MONITORING, INC.
UN03-4009
In Commercial Distribution

  • 00850015266904 ()


  • Electrical-only medical device connection cable, reusable
X24 LE Stat Device Kit Stratus
ADVANCED BRAIN MONITORING, INC.
XS30-1006.LE
In Commercial Distribution

  • 00850015266249 ()
  • 00850015266898 ()


  • Electroencephalograph
Headset Velcro Strap
ADVANCED BRAIN MONITORING, INC.
02-4105
In Commercial Distribution

  • 00850015266881 ()
  • 10850015266888 ()


  • Electrode/transducer strap, reusable
Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) Italian
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(ITA)
In Commercial Distribution

  • 00850015266874 ()
  • 00851113007949 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system
Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF)
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE
In Commercial Distribution

  • 00850015266867 ()
  • 00851113007949 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system
Sleep Profiler PSG2 LE Device Kit No Belts (PM3) German with cables
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE(GER)
In Commercial Distribution

  • 00850015266850 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph
Universal Strip Adapter Kit 10-20 LM Reduced
ADVANCED BRAIN MONITORING, INC.
XS30-4207
In Commercial Distribution

  • 00850015266843 ()


  • Patient monitoring system module, electroencephalographic
Arm & Chin EMG Cable Kit Polish
ADVANCED BRAIN MONITORING, INC.
SP29-4001.LE(POL)
In Commercial Distribution

  • 00850015266836 ()


  • Analytical non-scalp cutaneous lead
  • Electrocardiographic lead set, reusable
Sleep Profiler LE Device Kit Polish
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE(POL)
In Commercial Distribution

  • 00850015266829 ()


  • Electroencephalograph
Sleep Profiler LE Device Kit (Arm&Chin EMG) Polish
ADVANCED BRAIN MONITORING, INC.
SP29-1014.LE(POL)
In Commercial Distribution

  • 00850015266812 ()


  • Electroencephalograph
Dual Lead Cable 40" 3-Pin Kit Polish
ADVANCED BRAIN MONITORING, INC.
UN03-4008(POL)
In Commercial Distribution

  • 00850015266805 ()


  • Analytical non-scalp cutaneous lead
  • Electrocardiographic lead set, reusable
Dual Lead Cable Linked Mastoid Kit (Universal Strip)
ADVANCED BRAIN MONITORING, INC.
XS30-4001
In Commercial Distribution

  • 00850015266799 ()


  • Electrocardiographic lead set, reusable
Universal Strip Adapter Kit 10-20 Ref POz
ADVANCED BRAIN MONITORING, INC.
XS30-4205
In Commercial Distribution

  • 00850015266782 ()


  • Patient monitoring system module, electroencephalographic
Universal Strip Adapter Kit 10-20 LM
ADVANCED BRAIN MONITORING, INC.
XS30-4204
In Commercial Distribution

  • 00850015266775 ()


  • Patient monitoring system module, electroencephalographic
Medium 10-20 Universal Strip Kit (Qty 10)
ADVANCED BRAIN MONITORING, INC.
XS30-4252.10
In Commercial Distribution

  • 00850015266768 ()


  • Patient monitoring system module, electroencephalographic
Small 10-20 Universal Strip Kit (Qty 10)
ADVANCED BRAIN MONITORING, INC.
XS30-4251.10
In Commercial Distribution

  • 00850015266751 ()


  • Patient monitoring system module, electroencephalographic
Medium 10-20 Universal Strip
ADVANCED BRAIN MONITORING, INC.
XS30-4252
In Commercial Distribution

  • 00850015266744 ()


  • Patient monitoring system module, electroencephalographic
Small 10-20 Universal Strip
ADVANCED BRAIN MONITORING, INC.
XS30-4251
In Commercial Distribution

  • 00850015266737 ()


  • Patient monitoring system module, electroencephalographic
X-Small 10-20 Universal Strip Kit (Qty 5)
ADVANCED BRAIN MONITORING, INC.
XS30-4250.5
In Commercial Distribution

  • 00850015266720 ()


  • Patient monitoring system module, electroencephalographic
X-Small 10-20 Universal Strip
ADVANCED BRAIN MONITORING, INC.
XS30-4250
In Commercial Distribution

  • 00850015266713 ()


  • Patient monitoring system module, electroencephalographic
Sleep Profiler RTA Software
ADVANCED BRAIN MONITORING, INC.
SP42-5402
In Commercial Distribution

  • 00850015266706 ()


  • Polysomnography analyser
X24 LE Stat Device Kit Clinical
ADVANCED BRAIN MONITORING, INC.
XS30-1007.LE
In Commercial Distribution

  • 00850015266249 ()
  • 00850015266690 ()


  • Electroencephalograph
X24 LE Stat Device Kit
ADVANCED BRAIN MONITORING, INC.
XS30-1001.LE
In Commercial Distribution

  • 00850015266683 ()
  • 00850015266249 ()


  • Electroencephalograph
Sleep Profiler LE Device Kit Dutch
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE(DUT)
In Commercial Distribution

  • 00850015266676 ()


  • Electroencephalograph
Sleep Profiler PSG2 LE Device Kit No Belts (PM3) Italian with cables
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE(ITA)
In Commercial Distribution

  • 00850015266669 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph
X-Small 10-20 Single-Use Strip Kit (Qty 2 No Sensors)
ADVANCED BRAIN MONITORING, INC.
XS30-4210
In Commercial Distribution

  • 00850015266652 ()


  • Patient monitoring system module, electroencephalographic
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