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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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Bio Impedance analysis software ROW
IMPEDIMED LIMITED
5.5.0.1
In Commercial Distribution

  • B277299SFB7CD1 ()
  • B277299SFB7CD0 ()
299-SFB7CD

  • Bioelectrical body composition analyser
Bio Impedence analysis software US
IMPEDIMED LIMITED
5.5.0
In Commercial Distribution

  • B277293SFB7CD0 ()
  • B277293SFB7CD1 ()
293-SFB7CD

  • Bioelectrical body composition analyser
Single Tab Electrode, each pouch contains 100 single use gel backed electrodes.
IMPEDIMED LIMITED
292-STE
In Commercial Distribution

  • B277292STE2 ()
  • B277292STE1 ()
  • B277292STE0 ()
292-STE

  • Electrocardiographic electrode, single-use
Lymphederma Dual Tab Electrodes; each pouch contains 60 single use gel backed electrodes
IMPEDIMED LIMITED
292-DTE
In Commercial Distribution

  • B277292DTE1 ()
  • B277292DTE2 ()
  • B277292DTE08 ()
292-DTE

  • Electrocardiographic electrode, single-use
Body Composition Dual Tab Electrode, each pouch contains 60 single use gel backed electrodes.
IMPEDIMED LIMITED
292-BCE
In Commercial Distribution

  • B277292BCE2 ()
  • B277292BCE1 ()
  • B277292BCE0 ()
292-BCE

  • Electrocardiographic electrode, single-use
SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via dry electrode, and displaying the results on a monitor. (Repackaged for use in Clinical evaluations (Trials))
IMPEDIMED LIMITED
2826995
In Commercial Distribution

  • B27728269951 ()
  • B27728269950 ()
2826995

  • Bioelectrical body composition analyser
Quiet Expressions breast pump with Breastflow bottle
TOMY INTERNATIONAL, INC.
Y6228
In Commercial Distribution

  • B268Y62281 ()
  • B268Y62280 ()


  • Breast pump, electric
Quiet Expressions Plus Rechargeable Pump - Double
TOMY INTERNATIONAL, INC.
Y6053
In Commercial Distribution

  • B268Y60531 ()
  • B268Y60530 ()


  • Breast pump, electric
No Description
S D I DIAGNOSTICS INC
II
Not in Commercial Distribution

  • B279S298993200 ()
  • B279S298993050 ()
  • S2989930501 ()
29-8993-050

  • Pulmonary function testing filter/mouthpiece
Mouthpiece
S D I DIAGNOSTICS INC
Sense
In Commercial Distribution

  • B279S298050025 ()
  • B279S2980500251 ()
  • B279S298050100 ()
29-8050-025

  • Breathing mouthpiece, reusable
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