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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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Pathway - 00852423006073

Pathway® MR-10 Single Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-10
In Commercial Distribution

  • 00852423006073 ()
9700

  • Perineometer
  • Psychophysiological biofeedback system

Pathway - 00852423006066

Pathway® MR-15 Single Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-15
In Commercial Distribution

  • 00852423006066 ()
9715

  • Perineometer
  • Psychophysiological biofeedback system

Pathway - 00852423006059

Pathway® MR-20 Dual Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-20
In Commercial Distribution

  • 00852423006059 ()
9710

  • Perineometer
  • Psychophysiological biofeedback system

Pathway - 00852423006042

Pathway® MR-25 Dual Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-25
In Commercial Distribution

  • 00852423006042 ()
9725

  • Perineometer
  • Psychophysiological biofeedback system

BioSerenity-Link - 03615220003785

BioSerenity-Link is a mobile application capable of sharing phone connectivity, recording video and uploading it to the BioSerenity Cloud
BIOSERENITY MEDICAL DEVICES GROUP
5100-00021-UN
Not in Commercial Distribution

  • 03615220003785 ()


  • Camera application software
  • Medical networking interface unit

Spacelabs - 10841522108792

OPTION, SPACELABS SPO2, REFURBISHED
SPACELABS HEALTHCARE (WASHINGTON), INC
UV SL Command Module
Not in Commercial Distribution

  • 10841522108792 ()
R-91496-U

  • Patient monitoring system module, multifunction

Spacelabs - 10841522108785

OPTION, NELLCOR OXIMAX SPO2, REFURBISHED
SPACELABS HEALTHCARE (WASHINGTON), INC
UV SL Command Module
Not in Commercial Distribution

  • 10841522108785 ()
R-91496-N

  • Patient monitoring system module, multifunction

UltraviewSL - 10841522108778

OPTION, MASIMO SPO2, REFURBISHED
SPACELABS HEALTHCARE (WASHINGTON), INC
91496
Not in Commercial Distribution

  • 10841522108778 ()
R-91496-M

  • Patient monitoring system module, multifunction

UltraviewSL - 10841522107788

91496 UVSL COMMAND MODULE - NELLCOR
SPACELABS HEALTHCARE (WASHINGTON), INC
91496
Not in Commercial Distribution

  • 10841522107788 ()
L-91496-N

  • Patient monitoring system module, multifunction

UltraviewSL - 10841522107771

91496 UVSL COMMAND MODULE - MASIMO
SPACELABS HEALTHCARE (WASHINGTON), INC
91496
Not in Commercial Distribution

  • 10841522107771 ()
L-91496-M

  • Patient monitoring system module, multifunction
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