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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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Perfect Fit - 00817377022180

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

  • 00817377022180 ()


  • Polysomnograph

Perfect Fit - 00817377022173

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

  • 00817377022173 ()


  • Polysomnograph

Perfect Fit - 00817377022166

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

  • 00817377022166 ()


  • Polysomnograph

Perfect Fit - 00817377022104

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

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


  • Polysomnograph

Perfect Fit - 00817377022098

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

  • 00817377022098 ()


  • Polysomnograph

Perfect Fit - 00817377022081

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

  • 00817377022081 ()


  • Polysomnograph

Perfect Fit - 00817377022074

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

  • 00817377022074 ()


  • Polysomnograph

Perfect Fit - 00817377022067

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

  • 00817377022067 ()


  • Polysomnograph

Perfect Fit - 00817377022050

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

  • 00817377022050 ()


  • Polysomnograph

Perfect Fit - 00817377022043

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

  • 00817377022043 ()


  • Polysomnograph

Perfect Fit - 00817377022029

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

  • 00817377022029 ()


  • Polysomnograph

Perfect Fit - 00817377021947

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

  • 00817377021947 ()


  • Polysomnograph

Perfect Fit - 00817377021862

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

  • 00817377021862 ()


  • Polysomnograph

Perfect Fit - 00817377021855

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

  • 00817377021855 ()


  • Polysomnograph

Perfect Fit - 00817377021848

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

  • 00817377021848 ()


  • Polysomnograph

Perfect Fit - 00817377021831

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

  • 00817377021831 ()


  • Polysomnograph

Perfect Fit - 00817377021824

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 - 00817377021817

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

  • 00817377021817 ()


  • Polysomnograph

Perfect Fit - 00817377021800

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

  • 00817377021800 ()


  • Polysomnograph

Perfect Fit - 00817377021794

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

  • 00817377021794 ()


  • Polysomnograph

Perfect Fit - 00817377021787

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

  • 00817377021787 ()


  • Polysomnograph

Perfect Fit - 00817377021725

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

  • 00817377021725 ()


  • Polysomnograph

Perfect Fit - 00817377021718

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 - 00817377021701

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 - 00817377021695

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 - 00817377021688

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 - 00817377021671

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 - 00817377021664

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 - 00817377021657

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

Perfect Fit - 00817377021640

Perfect Fit™ II Adult Effort Belt Kit: 2 Sensors, 2-ea 45" & 60" Straps
DYMEDIX DIAGNOSTICS, INC.
18-14210-0602
In Commercial Distribution

  • 00817377021640 ()


  • Polysomnograph

Perfect Fit - 00817377021633

Perfect Fit Adult Effort Belt Kit: 2 sensors, 2 straps (45"), EFM, Alice 5
DYMEDIX DIAGNOSTICS, INC.
18-14204-0602
In Commercial Distribution

  • 00817377021633 ()


  • Polysomnograph

Perfect Fit - 00817377021626

Perfect Fit SUM Adult Effort Belt Kit: 2 sensors, 2 straps (45"), Sum EFM, Alice 5
DYMEDIX DIAGNOSTICS, INC.
18-14203-0602
In Commercial Distribution

  • 00817377021626 ()


  • Polysomnograph

Perfect Fit - 00817377021619

Perfect Fit Adult Effort Belt Kit: 2 sensors, 2 straps (45"), EFM
DYMEDIX DIAGNOSTICS, INC.
18-14202-0602
In Commercial Distribution

  • 00817377021619 ()


  • Polysomnograph

Perfect Fit - 00817377021602

Perfect Fit™SUM Adult Effort Belt Kit: 2 sensors, 2 straps (45"), Sum Interface Cable
DYMEDIX DIAGNOSTICS, INC.
18-14201-0602
In Commercial Distribution

  • 00817377021602 ()


  • Polysomnograph

Perfect Fit - 00817377021596

Perfect Fit™ 3D REUSABLE-Disposable Kit includes: 2- Perfect Fit™3-D sensors, 5-50 yard rolls of Effort Belt Strap, Grael
DYMEDIX DIAGNOSTICS, INC.
18-13205-0001
In Commercial Distribution

  • 00817377021596 ()


  • Polysomnograph

Perfect Fit - 00817377021589

Perfect Fit™ 3D REUSABLE-Disposable Kit includes: 2- Perfect Fit™3-D sensors, 5-50 yard rolls of Effort Belt Strap, Alice 6
DYMEDIX DIAGNOSTICS, INC.
18-13204-0001
In Commercial Distribution

  • 00817377021589 ()


  • Polysomnograph

Perfect Fit - 00817377021572

Perfect Fit™ 3D REUSABLE-Disposable Kit includes: 2- Perfect Fit™3-D sensors, 5-50 yard rolls of Effort Belt Strap, Embla N7000
DYMEDIX DIAGNOSTICS, INC.
18-13203-0001
In Commercial Distribution

  • 00817377021572 ()


  • Polysomnograph

Perfect Fit - 00817377021565

Perfect Fit™ 3D REUSABLE-Disposable Kit includes: 2- Perfect Fit™3-D sensors, 5-50 yard rolls of Effort Belt Strap, Embla
DYMEDIX DIAGNOSTICS, INC.
18-13202-0001
In Commercial Distribution

  • 00817377021565 ()


  • Polysomnograph

Perfect Fit - 00817377021558

Perfect Fit™ 3D REUSABLE-Disposable Kit includes: 2- Perfect Fit™3-D sensors, 5-50 yard rolls of Effort Belt Strap, Alice 5
DYMEDIX DIAGNOSTICS, INC.
18-13201-0001
In Commercial Distribution

  • 00817377021558 ()


  • Polysomnograph

Perfect Fit - 00817377021541

Perfect Fit™ 3D REUSABLE-Disposable Kit includes: 2- Perfect Fit™3-D sensors, 5-50 yard rolls of Effort Belt Strap, 1.5 mm
DYMEDIX DIAGNOSTICS, INC.
18-13200-0001
In Commercial Distribution

  • 00817377021541 ()


  • Polysomnograph
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