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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FastTrack Demo Kit, Pediatric, Alice 5
DYMEDIX DIAGNOSTICS, INC.
18-01016-0301
In Commercial Distribution

  • 00817377022180 ()


  • Polysomnograph
FastTrack Demo Kit, Adult, Universal
DYMEDIX DIAGNOSTICS, INC.
18-01015-0601
In Commercial Distribution

  • 00817377022173 ()


  • Polysomnograph
FastTrack Demo Kit, Pediatric, Universal
DYMEDIX DIAGNOSTICS, INC.
18-01015-0301
In Commercial Distribution

  • 00817377022166 ()


  • Polysomnograph
FastTrack Effort Pack, Pediatric
DYMEDIX DIAGNOSTICS, INC.
11-44000-3002
In Commercial Distribution

  • 00817377022104 ()
  • 00817377022135 ()
  • 00817377022128 ()


  • Polysomnograph
Interface Cable, FastTrack, Chest, Alice 6
DYMEDIX DIAGNOSTICS, INC.
12-42017-0001
In Commercial Distribution

  • 00817377022098 ()


  • Polysomnograph
Interface Cable, FastTrack, Abdomen, Alice 6
DYMEDIX DIAGNOSTICS, INC.
12-42016-0001
In Commercial Distribution

  • 00817377022081 ()


  • Polysomnograph
Interface Cable, FastTrack, Chest, Grael
DYMEDIX DIAGNOSTICS, INC.
12-42015-0001
In Commercial Distribution

  • 00817377022074 ()


  • Polysomnograph
Interface Cable, FastTrack, Abdomen, Grael
DYMEDIX DIAGNOSTICS, INC.
12-42014-0001
In Commercial Distribution

  • 00817377022067 ()


  • Polysomnograph
Interface Cable, FastTrack, Chest, Embla
DYMEDIX DIAGNOSTICS, INC.
12-42013-0001
In Commercial Distribution

  • 00817377022050 ()


  • Polysomnograph
Interface Cable, FastTrack, Abdomen, Embla
DYMEDIX DIAGNOSTICS, INC.
12-42012-0001
In Commercial Distribution

  • 00817377022043 ()


  • Polysomnograph
Interface Cable, FastTrack, Abdomen, Alice 5
DYMEDIX DIAGNOSTICS, INC.
12-42010-0001
In Commercial Distribution

  • 00817377022029 ()


  • Polysomnograph
Interface Cable, Fast Track, Chest
DYMEDIX DIAGNOSTICS, INC.
12-10152-0001
In Commercial Distribution

  • 00817377021947 ()


  • Polysomnograph
Perfect Fit II Adult Effort Belt Sensor, Abdomen, NOX-T3
DYMEDIX DIAGNOSTICS, INC.
11-42407-0601
In Commercial Distribution

  • 00817377021862 ()


  • Polysomnograph
Perfect Fit II Adult Effort Belt Sensor, Chest, NOX-T3
DYMEDIX DIAGNOSTICS, INC.
11-42307-0601
In Commercial Distribution

  • 00817377021855 ()


  • Polysomnograph
Perfect Fit 3D Effort Module, Chest, NOX-T3
DYMEDIX DIAGNOSTICS, INC.
11-45009-0002
In Commercial Distribution

  • 00817377021848 ()


  • Polysomnograph
Perfect Fit 3D Effort Module, Abdomen, NOX-T3
DYMEDIX DIAGNOSTICS, INC.
11-45009-0001
In Commercial Distribution

  • 00817377021831 ()


  • Polysomnograph
Perfect Fit™ 3D REUSABLE-Disposable Kit includes: 2- Perfect Fit™3-D sensors, 5-50 yard rolls of Effort Belt Strap, Keyhole
DYMEDIX DIAGNOSTICS, INC.
18-13206-0001
In Commercial Distribution

  • 00817377021824 ()


  • Polysomnograph
Perfect Fit™ 3D Effort Belt Sensor, Abdomen, Nomad
DYMEDIX DIAGNOSTICS, INC.
11-45008-0001
In Commercial Distribution

  • 00817377021817 ()


  • Polysomnograph
Perfect Fit™ 3D Effort Belt Sensor, Chest, Nomad
DYMEDIX DIAGNOSTICS, INC.
11-45008-0002
In Commercial Distribution

  • 00817377021800 ()


  • Polysomnograph
Perfect Fit™ 3D Effort Belt Sensor, Chest, Keyhole
DYMEDIX DIAGNOSTICS, INC.
11-45006-0002
In Commercial Distribution

  • 00817377021794 ()


  • Polysomnograph
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