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 Effort Pack, Adult
DYMEDIX DIAGNOSTICS, INC.
11-44000-7502
In Commercial Distribution

  • 00817377022111 ()
  • 00817377022159 ()
  • 00817377022142 ()


  • 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, Chest, Alice 5
DYMEDIX DIAGNOSTICS, INC.
12-42011-0001
In Commercial Distribution

  • 00817377022036 ()


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

  • 00817377022029 ()


  • Polysomnograph
FastTrack Effort Interface Kit
DYMEDIX DIAGNOSTICS, INC.
18-01800-0001
In Commercial Distribution

  • 00817377022012 ()


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

  • 00817377021947 ()


  • Polysomnograph
Interface Cable, Fast Track, Abdomen
DYMEDIX DIAGNOSTICS, INC.
12-10151-0001
In Commercial Distribution

  • 00817377021930 ()


  • 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
Perfect Fit™ 3D Effort Belt Sensor, Abdomen, Keyhole
DYMEDIX DIAGNOSTICS, INC.
11-45006-0001
In Commercial Distribution

  • 00817377021787 ()


  • Polysomnograph
Cadwell Sensor Kit, Adult, Disposable
DYMEDIX DIAGNOSTICS, INC.
18-14240-0602
In Commercial Distribution

  • 00817377021725 ()


  • Polysomnograph
Cadwell ApneaTrak Adult Effort Belt Kit: 2 sensors, 2 ea-45", 60" Straps
DYMEDIX DIAGNOSTICS, INC.
18-14230-0602
In Commercial Distribution

  • 00817377021718 ()


  • Polysomnograph
Perfect Fit™ II R/S Adult Kit includes: 2- Perfect Fit™ II R/S sensors, 2-45” Effort Belt Straps, 2-60” Effort Belt Straps, and 2- R/S Interface Cables, Alice 6
DYMEDIX DIAGNOSTICS, INC.
18-14216-0602
In Commercial Distribution

  • 00817377021701 ()


  • Polysomnograph
Perfect Fit™ II R/S Adult Kit includes: 2- Perfect Fit™ II R/S sensors, 2-45” Effort Belt Straps, 2-60” Effort Belt Straps, and 2- R/S Interface Cables, Grael
DYMEDIX DIAGNOSTICS, INC.
18-14215-0602
In Commercial Distribution

  • 00817377021695 ()


  • Polysomnograph
Perfect Fit™ II R/S Adult Kit includes: 2- Perfect Fit™ II R/S sensors, 2-45” Effort Belt Straps, 2-60” Effort Belt Straps, and 2- R/S Interface Cables, Embla, 1.5 mm
DYMEDIX DIAGNOSTICS, INC.
18-14214-0602
In Commercial Distribution

  • 00817377021688 ()


  • Polysomnograph
Perfect Fit™ II R/S Adult Kit includes: 2- Perfect Fit™ II R/S sensors, 2-45” Effort Belt Straps, 2-60” Effort Belt Straps, and 2- R/S Interface Cables, Embla
DYMEDIX DIAGNOSTICS, INC.
18-14213-0602
In Commercial Distribution

  • 00817377021671 ()


  • Polysomnograph
Perfect Fit ™II Adult Effort Belt Kit: 2 Sensors, 2-ea 45" & 60" Straps, Alice® 3
DYMEDIX DIAGNOSTICS, INC.
18-14212-0602
In Commercial Distribution

  • 00817377021664 ()


  • Polysomnograph
Perfect Fit ™II Adult Effort Belt Kit: 2 Sensors, 2-ea 45" & 60" Straps, Alice® 5
DYMEDIX DIAGNOSTICS, INC.
18-14211-0602
In Commercial Distribution

  • 00817377021657 ()


  • Polysomnograph
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