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™ 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
Cadwell ApneaTrak Pediatric Effort Belt Kit: 2 sensors, 2 ea-15",25",35" Straps
DYMEDIX DIAGNOSTICS, INC.
18-12230-0302
In Commercial Distribution

  • 00817377021534 ()


  • 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, Alice 6
DYMEDIX DIAGNOSTICS, INC.
18-12216-0302
In Commercial Distribution

  • 00817377021527 ()


  • 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, Grael
DYMEDIX DIAGNOSTICS, INC.
18-12215-0302
In Commercial Distribution

  • 00817377021510 ()


  • 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 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
DYMEDIX DIAGNOSTICS, INC.
18-12213-0302
In Commercial Distribution

  • 00817377021497 ()


  • 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
Perfect Fit™ II Pediatric Effort Belt Kit: 2 Sensors, 2-ea 15", 25", 35" straps, Alice® 5
DYMEDIX DIAGNOSTICS, INC.
18-12211-0302
In Commercial Distribution

  • 00817377021473 ()


  • Polysomnograph
Perfect Fit™ II Pediatric Effort Belt Kit: 2 Sensors, 2-ea 15", 25", 35" straps
DYMEDIX DIAGNOSTICS, INC.
18-12210-0302
In Commercial Distribution

  • 00817377021466 ()


  • Polysomnograph
Perfect Fit Pediatric Effort Belt Kit: 2 sensors, 2 ea-15",25",35" Straps, EFM Alice 5
DYMEDIX DIAGNOSTICS, INC.
18-12204-0302
In Commercial Distribution

  • 00817377021459 ()


  • Polysomnograph
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