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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No Description
EARLYSENSE LTD
N/A
In Commercial Distribution

  • 17290016169109 ()
  • 07290016169102 ()
AME-01340-02 US

  • General-purpose multi-parameter bedside monitor
No Description
EARLYSENSE LTD
N/A
In Commercial Distribution

  • 07290016169065 ()
AME-00271 US

  • Patient monitoring system module, multifunction
A non-sterile, single use electrode set designed to be adhered across a patient's chest and connected to the ExSpiron Monitor for impedance pneumography. Consists of electrodes and lead wire to allow for impedance measurements across a chest cavity.
Senzime AB (Publ.)
Pediatric
In Commercial Distribution

  • 00851540007161 ()
RMI-53040

  • Monitoring spirometer, electrical
A noninvasive device designed to continuously measure a patient's tidal volume, minute ventilation, and respiratory rate via impedance pneumography. Designed to be connected to the ExSpiron PadSet via the ExSpiron Patient Cable, the ExSpiron 2Xi Monitor provides a measurement of a patient's respiratory parameters, while also incorporating alarms. The ExSpiron 2Xi Monitor can be integrated into a medical facility's nurse call system.
Senzime AB (Publ.)
RMI-54000
In Commercial Distribution

  • 00851540007147 ()
  • 00851540007154 ()


  • Monitoring spirometer, electrical
Assembly designed to be integrated into medical facility infrastructure in order to trigger a nurse call alarm system. Designed to be used only with the ExSpiron 1Xi Monitor.
Respiratory Motion Inc.
Nurse Call Module
In Commercial Distribution

  • 00851540007055 ()
  • 00851540007079 ()
RMI-51155

  • Nurse call system
Insulated, reusable, medical grade electrical cord design to enable connection of the ExSpiron 1Xi to a mains electricity supply socket, with a NEMA 5-15P plug and an IEC 60320-C13 connector at either end.
Respiratory Motion Inc.
Power Cord, 10'
In Commercial Distribution

  • 00851540007024 ()
  • 00851540007109 ()
RMI-51250

  • Electrical mains power cable
A noninvasive device designed to continuously measure a patient's tidal volume, minute ventilation, and respiratory rate via impedance pneumography. Designed to be connected to the ExSpiron 1Xi PadSet via the ExSpiron 1Xi Patient Cable, the ExSpiron 1Xi Monitor provides a measurement of a patient's respiratory parameters, while also incorporating alarms. The ExSpiron 1Xi Monitor can be integrated into a medical facility's nurse call system via the ExSpiron 1Xi Nurse Call Module.
Respiratory Motion Inc.
Monitor
In Commercial Distribution

  • 00851540007000 ()
  • 00851540007031 ()
RMI-51000

  • Monitoring spirometer, electrical
A non-sterile, single use electrode set designed to be adhered across a patient's chest and connected to the ExSpiron Monitor for impedance pneumography. Consists of electrodes and lead wire to allow for impedance measurements across a chest cavity.
Senzime AB (Publ.)
Adult
In Commercial Distribution

  • 00851540007048 ()
  • 00851540007116 ()
RMI-51110

  • Monitoring spirometer, electrical
Noninvasive, insulated, electrical cable designed to connect the ExSpiron Monitor to the ExSpiron PadSet.
Respiratory Motion Inc.
Patient Cable, 8'
In Commercial Distribution

  • 00851540007017 ()
  • 00851540007093 ()
RMI-51130

  • Monitoring spirometer, electrical
No Description
Xandar Kardian Korea Inc.
XK300
Not in Commercial Distribution

  • 08809988780001 ()


  • Multiple vital physiological parameter monitoring system, home-use
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