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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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X-Series - 00850015266898

X24 LE Stat Device Kit Stratus
ADVANCED BRAIN MONITORING, INC.
XS30-1006.LE
In Commercial Distribution

  • 00850015266249 ()
  • 00850015266898 ()


  • Electroencephalograph

X-Series - 00850015266881

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

  • 00850015266881 ()
  • 10850015266888 ()


  • Electrode/transducer strap, reusable

Sleep Profiler PSG2 - 00850015266874

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 - 00850015266867

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 - 00850015266850

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

X-Series - 00850015266843

Universal Strip Adapter Kit 10-20 LM Reduced
ADVANCED BRAIN MONITORING, INC.
XS30-4207
In Commercial Distribution

  • 00850015266843 ()


  • Patient monitoring system module, electroencephalographic

X-Series, X8 - 00850015266836

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 - 00850015266829

Sleep Profiler LE Device Kit Polish
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE(POL)
In Commercial Distribution

  • 00850015266829 ()


  • Electroencephalograph

Sleep Profiler - 00850015266812

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

  • 00850015266812 ()


  • Electroencephalograph

X-Series, X8 - 00850015266805

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

X-Series - 00850015266799

Dual Lead Cable Linked Mastoid Kit (Universal Strip)
ADVANCED BRAIN MONITORING, INC.
XS30-4001
In Commercial Distribution

  • 00850015266799 ()


  • Electrocardiographic lead set, reusable

X-Series - 00850015266782

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

  • 00850015266782 ()


  • Patient monitoring system module, electroencephalographic

X-Series - 00850015266775

Universal Strip Adapter Kit 10-20 LM
ADVANCED BRAIN MONITORING, INC.
XS30-4204
In Commercial Distribution

  • 00850015266775 ()


  • Patient monitoring system module, electroencephalographic

X-Series - 00850015266768

Medium 10-20 Universal Strip Kit (Qty 10)
ADVANCED BRAIN MONITORING, INC.
XS30-4252.10
In Commercial Distribution

  • 00850015266768 ()


  • Patient monitoring system module, electroencephalographic

X-Series - 00850015266751

Small 10-20 Universal Strip Kit (Qty 10)
ADVANCED BRAIN MONITORING, INC.
XS30-4251.10
In Commercial Distribution

  • 00850015266751 ()


  • Patient monitoring system module, electroencephalographic

X-Series - 00850015266744

Medium 10-20 Universal Strip
ADVANCED BRAIN MONITORING, INC.
XS30-4252
In Commercial Distribution

  • 00850015266744 ()


  • Patient monitoring system module, electroencephalographic

X-Series - 00850015266737

Small 10-20 Universal Strip
ADVANCED BRAIN MONITORING, INC.
XS30-4251
In Commercial Distribution

  • 00850015266737 ()


  • Patient monitoring system module, electroencephalographic

X-Series - 00850015266720

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-Series - 00850015266713

X-Small 10-20 Universal Strip
ADVANCED BRAIN MONITORING, INC.
XS30-4250
In Commercial Distribution

  • 00850015266713 ()


  • Patient monitoring system module, electroencephalographic

Sleep Profiler - 00850015266706

Sleep Profiler RTA Software
ADVANCED BRAIN MONITORING, INC.
SP42-5402
In Commercial Distribution

  • 00850015266706 ()


  • Polysomnography analyser

X-Series - 00850015266690

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

  • 00850015266249 ()
  • 00850015266690 ()


  • Electroencephalograph

X-Series - 00850015266683

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

  • 00850015266683 ()
  • 00850015266249 ()


  • Electroencephalograph

Sleep Profiler - 00850015266676

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

  • 00850015266676 ()


  • Electroencephalograph

Sleep Profiler PSG2 - 00850015266669

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-Series - 00850015266652

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

X-Series - 00850015266645

Medium 10-20 Single-Use Strip Kit (No Sensors)
ADVANCED BRAIN MONITORING, INC.
XS30-4212
In Commercial Distribution

  • 00850015266645 ()


  • Patient monitoring system module, electroencephalographic

X-Series - 00850015266638

Small 10-20 Single-Use Strip Kit (No Sensors)
ADVANCED BRAIN MONITORING, INC.
XS30-4211
In Commercial Distribution

  • 00850015266638 ()


  • Patient monitoring system module, electroencephalographic

X-Series - 00850015266614

Single-Use Strip Sensor Kit
ADVANCED BRAIN MONITORING, INC.
XS30-4301
In Commercial Distribution

  • 00850015266614 ()


  • Patient monitoring system module, electroencephalographic

Sleep Profiler - 00850015266607

Sleep Profiler LE Device Kit (Arm&Chin EMG) Italian
ADVANCED BRAIN MONITORING, INC.
SP29-1014.LE(ITA)
In Commercial Distribution

  • 00850015266607 ()


  • Electroencephalograph

Sleep Profiler - 00850015266591

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

  • 00850015266591 ()


  • Electroencephalograph

X-Series, X8 - 00850015266584

Dual Lead Cable 40" 3-Pin Kit Italian
ADVANCED BRAIN MONITORING, INC.
UN03-4008(ITA)
In Commercial Distribution

  • 00850015266584 ()


  • Analytical non-scalp cutaneous lead
  • Electrocardiographic lead set, reusable

X-Series, X8 - 00850015266577

Arm & Chin EMG Cable Kit Italian
ADVANCED BRAIN MONITORING, INC.
SP29-4001.LE(ITA)
In Commercial Distribution

  • 00850015266577 ()


  • Analytical non-scalp cutaneous lead
  • Electrocardiographic lead set, reusable

X-Series, X8 - 00850015266560

Arm & Chin EMG Cable Kit
ADVANCED BRAIN MONITORING, INC.
SP29-4001.LE
In Commercial Distribution

  • 00850015266560 ()


  • Analytical non-scalp cutaneous lead
  • Electrocardiographic lead set, reusable

X-Series, X8 - 00850015266553

Dual Lead Cable 40" 3-Pin Kit
ADVANCED BRAIN MONITORING, INC.
UN03-4008
In Commercial Distribution

  • 00850015266553 ()


  • Analytical non-scalp cutaneous lead
  • Electrocardiographic lead set, reusable

Sleep Profiler PSG2 - 00850015266546

Sleep Profiler PSG2 LE Device Kit No Belts (PM3) German
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE(GER)
In Commercial Distribution

  • 00850015266546 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph

Sleep Profiler - 00850015266539

Sleep Profiler LE Device Kit German
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE(GER)
In Commercial Distribution

  • 00850015266539 ()


  • Electroencephalograph

Sleep Profiler - 00850015266522

Sleep Profiler LE Device Kit Italian
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE(ITA)
In Commercial Distribution

  • 00850015266522 ()


  • Electroencephalograph

Night Shift - 00850015266515

Night Shift Chest Belt Extension Kit
ADVANCED BRAIN MONITORING, INC.
NS27-4103
In Commercial Distribution

  • 00850015266515 ()


  • Behavioural therapy electrical stimulation system

Apnea Guard - 00850015266485

Apnea Guard Starter Kit 1L2M2H UK
ADVANCED BRAIN MONITORING, INC.
AG25-1015(UK)
In Commercial Distribution

  • 00850015266485 ()


  • Mandible-repositioning sleep-disordered breathing orthosis

Apnea Guard - 00850015266478

Apnea Guard Starter Kit 2L2M1H UK
ADVANCED BRAIN MONITORING, INC.
AG25-1012(UK)
In Commercial Distribution

  • 00850015266478 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
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