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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 - 00851113007987

Sleep Profiler PSG2 LE Device Kit - Piezo
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE, SP29-1009.LE
In Commercial Distribution

  • 00851113007949 ()
  • 00851113007987 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system

Sleep Profiler PSG2 - 00851113007970

Sleep Profiler PSG2 LE Device kit - ezRIP
ADVANCED BRAIN MONITORING, INC.
SP29-1001.LE, SP29-1008.LE
In Commercial Distribution

  • 00851113007949 ()
  • 00851113007970 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph

Sleep Profiler PSG2 - 00851113007963

Sleep Profiler PSG2 LE Device Kit No Belts (PM3)
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE, SP29-1007.LE
In Commercial Distribution

  • 00851113007949 ()
  • 00851113007963 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph

Sleep Profiler - 00851113007956

Sleep Profiler LE Device Kit
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE, SP29-1003.LE
In Commercial Distribution

  • 00851113007949 ()
  • 00851113007956 ()


  • Electroencephalograph

X-Series - 00851113007925

X24 Stat Device Kit - ESU (PAN 1026A)
ADVANCED BRAIN MONITORING, INC.
XS30-1001
In Commercial Distribution

  • 00851113007925 ()
  • 00851113007345 ()


  • Electroencephalograph

X-Series - 00851113007857

X10 Stat Device Kit (PAN 1026)
ADVANCED BRAIN MONITORING, INC.
XS30-1004, XS30-1005
In Commercial Distribution

  • 00851113007857 ()


  • Electroencephalograph

X-Series - 00851113007840

X24 Stat Device kit - Dongle (PAN 1026)
ADVANCED BRAIN MONITORING, INC.
XS30-1002, XS30-1003
In Commercial Distribution

  • 00851113007840 ()


  • Electroencephalograph

X-Series - 00851113007826

X10 Stat Device Kit
ADVANCED BRAIN MONITORING, INC.
XS30-1004, XS30-1005
In Commercial Distribution

  • 00851113007345 ()
  • 00851113007826 ()


  • Electroencephalograph

Sleep Profiler - 00851113007741

Sleep Profiler System Kit - TRL
ADVANCED BRAIN MONITORING, INC.
SP40-1003
In Commercial Distribution

  • 00851113007741 ()


  • Electroencephalograph

X-Series - 00851113007734

X24 Stat Device Kit - TRL
ADVANCED BRAIN MONITORING, INC.
XS24-1003
In Commercial Distribution

  • 00851113007628 ()
  • 00851113007734 ()


  • Electroencephalograph
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