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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Hub Holster
NONIN MEDICAL, INC.
X-100HH
In Commercial Distribution

  • 00833166002201 ()
  • 00849686073492 ()


  • Pulse oximeter
  • Cerebral oximeter
  • Pulse oximeter, line-powered
Universal Oximetry Signal Processor, Channel 2
NONIN MEDICAL, INC.
X-100SP-2
In Commercial Distribution

  • 00849686086591 ()
  • 00849686072877 ()
  • 00833166002065 ()


  • Pulse oximeter
  • Cerebral oximeter
  • Pulse oximeter, line-powered
Universal Oximetry Signal Processor, Channel 3
NONIN MEDICAL, INC.
X-100SP-3
In Commercial Distribution

  • 00849686086584 ()
  • 00849686072860 ()
  • 00833166002058 ()
  • 00849686075663 ()


  • Pulse oximeter
  • Cerebral oximeter
  • Pulse oximeter, line-powered
Universal Oximetry Signal Processor, channel 4
NONIN MEDICAL, INC.
X-100SP-4
In Commercial Distribution

  • 00849686086577 ()
  • 00849686072853 ()
  • 00833166002041 ()
  • 00849686075656 ()


  • Cerebral oximeter
  • Pulse oximeter
  • Pulse oximeter, line-powered
SenSmart Universal Oximetry System
NONIN MEDICAL, INC.
X-100
In Commercial Distribution

  • 00833166002508 ()
  • 00849686073577 ()
  • 00849686086324 ()
  • 00849686066982 ()
  • 00849686066180 ()


  • Cerebral oximeter
  • Pulse oximeter
  • Pulse oximeter, line-powered
Universal Signal Processor, Channel 1
NONIN MEDICAL, INC.
X-100SP-1
In Commercial Distribution

  • 00849686075687 ()
  • 00849686072884 ()
  • 00849686086607 ()
  • 00833166002072 ()


  • Pulse oximeter
  • Cerebral oximeter
  • Pulse oximeter, line-powered
Universal Oximetry Signal Processor, Channel 5
NONIN MEDICAL, INC.
X-100SP-5
In Commercial Distribution

  • 00849686086560 ()
  • 00849686072846 ()
  • 00833166002034 ()
  • 00849686075649 ()


  • Cerebral oximeter
  • Pulse oximeter
  • Pulse oximeter, line-powered
Vitals360 Multi-Vitals Mobile Monitor VC-001
Vocare, Inc.
VC-001
In Commercial Distribution

  • 10860007323406 ()
  • 00860007323409 ()
  • 20860007323403 ()
  • 30860007323400 ()


  • Pulse oximeter
  • Infrared patient thermometer, skin
  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
  • Multiple vital physiological parameter monitoring system, clinical
Hand Held Massager
Therabody, Inc.
Theragun PRO PLUS
In Commercial Distribution

  • 00840295401874 ()


  • Hand-held electric massager
  • Hot/cold therapy pack, reusable
  • Blue/red/infrared phototherapy lamp
  • Pulse oximeter
The Vios Monitoring System (VMS) Bedside Monitor (BSM) is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters. The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment. VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected. The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions. The VMS BSM is intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
BSM2050 Software
In Commercial Distribution

  • B595BSM20500 ()
BSM2050

  • Pulse oximeter
  • General-purpose multi-parameter bedside monitor
  • Cardiac arrhythmia monitoring system
  • Pulse Co-oximeter probe, reusable
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