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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SnuggleFit Infant Effort Belt - Alice 5
DYMEDIX DIAGNOSTICS, INC.
18-13301-0001
In Commercial Distribution

  • 00817377022548 ()


  • Polysomnograph
SnuggleFit Infant Effort Belt - Universal
DYMEDIX DIAGNOSTICS, INC.
18-13300-0001
In Commercial Distribution

  • 00817377022531 ()


  • Polysomnograph
SnuggleFit Effort Belt Roll, 50 yard roll
DYMEDIX DIAGNOSTICS, INC.
11-14002-5001
In Commercial Distribution

  • 00817377022517 ()
  • 00817377022524 ()


  • Polysomnograph
FastTrack Demo Kit, Adult, Alice 5
DYMEDIX DIAGNOSTICS, INC.
18-01016-0601
In Commercial Distribution

  • 00817377022197 ()


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

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


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

  • 00817377022036 ()


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

  • 00817377022012 ()


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

  • 00817377021930 ()


  • Polysomnograph
Perfect Fit™ II R/S Pediatric Kit includes: 2- Perfect Fit™II R/S sensors, 2-15” Effort Belt Strap, 2-25” Effort Belt Strap, and 2-35” Effort Belt Strap and 2- R/S Interface Cable, Embla, 1.5 mm
DYMEDIX DIAGNOSTICS, INC.
18-12214-0302
In Commercial Distribution

  • 00817377021503 ()


  • Polysomnograph
Perfect Fit™ II Pediatric Effort Belt Kit: 2 Sensors, 2-ea 15", 25", 35" straps, Alice® 3
DYMEDIX DIAGNOSTICS, INC.
18-12212-0302
In Commercial Distribution

  • 00817377021480 ()


  • Polysomnograph
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