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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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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
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
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
Convenience kit with Avazzia Life Pinnacle device, conductive pads, Y electrode accessory, brush electrode accessory, lead wires, batteries, instruction manual and carry case.
AVAZZIA INC
A4-AP-K
In Commercial Distribution

  • 00851530007782 ()
A4-AP-K

  • Analgesic transcutaneous electrical nerve stimulation system
Convenience kit with Avazzia Life Genesis OTC device, conductive pads, lead wire, and pouch.
AVAZZIA INC
A4-AG-K OTC
In Commercial Distribution

  • 00851530007768 ()
A4-AG-K OTC

  • Analgesic transcutaneous electrical nerve stimulation system
Convenience kit with Avazzia Life Genesis OTC device, conductive pads, Y electrode, lead wires, and carry case.
AVAZZIA INC
A4-AG-K-Y OTC
In Commercial Distribution

  • 00851530007751 ()
A4-AG-K-Y OTC

  • Analgesic transcutaneous electrical nerve stimulation system
Convenience kit with Avazzia Life Evolution device, conductive pads, Y electrode, lead wires, and carry case.
AVAZZIA INC
A4-AE-K-Y
In Commercial Distribution

  • 00851530007737 ()
A4-AE-K-Y

  • Analgesic transcutaneous electrical nerve stimulation system
Convenience kit with Med Sport OTC device, conductive pads, Y electrode, lead wires, and carry case.
AVAZZIA INC
A4-MS-K-Y OTC
In Commercial Distribution

  • 00851530007706 ()
A4-MS-K-Y-OTC

  • Analgesic transcutaneous electrical nerve stimulation system
Convenience kit with Med Sport OTC device, conductive pads, lead wire, and zipper pouch
AVAZZIA INC
A4-MS-K OTC
In Commercial Distribution

  • 00851530007690 ()
A4-MS-K-OTC

  • Analgesic transcutaneous electrical nerve stimulation system
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