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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Tabletop Pulse Oximeter
NONIN MEDICAL, INC.
9600
In Commercial Distribution

  • 00833166001365 ()
  • 00849686073638 ()
  • 00833166001914 ()
  • 00849686067736 ()


  • Pulse oximeter, line-powered
  • Pulse oximeter
Tabletop Pulse Oximeter with Waveform
NONIN MEDICAL, INC.
9700
In Commercial Distribution

  • 00833166001372 ()
  • 00849686073621 ()


  • Pulse oximeter, line-powered
  • Pulse oximeter
ANNE Limb is a pulse oximeter intended for continuous monitoring of SpO2, pulse rate, and skin temperature.
Sibel Health Inc.
810-00013
In Commercial Distribution

  • 00860004541752 ()


  • Pulse oximeter
  • Wearable multiple vital physiological parameter monitor
No Description
Sibel Health Inc.
900-00042
In Commercial Distribution

  • 00850064210231 ()


  • Wearable multiple physiological parameter recorder, reusable
  • Pulse oximeter
No Description
Sibel Health Inc.
900-00041
In Commercial Distribution

  • 00850064210217 ()


  • Wearable multiple physiological parameter recorder, reusable
  • Pulse oximeter
No Description
Sibel Health Inc.
810-00013
In Commercial Distribution

  • 00850064210156 ()


  • Wearable multiple physiological parameter recorder, reusable
  • Pulse oximeter
ANNE Limb is a pulse oximeter intended for continuous monitoring of SpO2, pulse rate, and skin temperature.
Sibel Health Inc.
900-00003
In Commercial Distribution

  • 00850064210088 ()


  • Pulse oximeter
  • Wearable multiple physiological parameter recorder, reusable
Smart Spirometer and Oximeter connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Spirobank Oxi
In Commercial Distribution

  • 08052990321711 ()


  • Expiratory peak flow meter, digital
  • Pulse oximeter
Smart Spirometer and Oximeter connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Smart One Oxi
In Commercial Distribution

  • 08052990321704 ()


  • Expiratory peak flow meter, digital
  • Pulse oximeter
WristOx2 Wearable Pulse Oximeter with Bluetooth
NONIN MEDICAL, INC.
3150
In Commercial Distribution

  • 00833166003390 ()
  • 00849686073782 ()
  • 00833166003420 ()
  • 00833166009170 ()


  • Pulse oximetry telemetric monitoring system
  • Pulse oximeter
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