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™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™ 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™ 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™ 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™ 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™ 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™ 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
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