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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PORTRAIT SpO2 P-SA FINAL DEVICE ASSEMBLY
GE Healthcare Finland Oy
P-SA01
In Commercial Distribution

  • 00195278264831 ()
2103502-001

  • Pulse oximeter probe/processor
PORTRAIT SpO2 P-SE FINAL DEVICE ASSEMBLY
GE Healthcare Finland Oy
P-SE01
In Commercial Distribution

  • 00195278264824 ()
2104044-001

  • Pulse oximeter probe/processor
PORTRAIT RR P-RR FINAL DEVICE ASSEMBLY
GE Healthcare Finland Oy
P-RR01
In Commercial Distribution

  • 00195278264817 ()
2103567-001

  • Respiration rate signal processor/transmitter
PORTRAIT SpO2 P-W FINAL DEVICE ASSEMBLY
GE Healthcare Finland Oy
P-W01
In Commercial Distribution

  • 00195278264800 ()
2096441-001

  • Pulse oximeter probe/processor
PORTRAIT SpO2 P-SP FINAL DEVICE ASSEMBLY
GE Healthcare Finland Oy
P-SP01
In Commercial Distribution

  • 00195278264794 ()
2104045-001

  • Pulse oximeter probe/processor
BODY-WORN RESP ELECTRODE PATCH
GE Healthcare Finland Oy
RRP01
In Commercial Distribution

  • 00195278229229 ()
  • 00195278223401 ()
  • 00195278699893 ()
5514119

  • Thoracic electrical impedance electrode array, single-use
Portrait AAB01 SpO2 attachment accessory band, PKG of 30 PCS
GE Healthcare Finland Oy
AAB01
In Commercial Distribution

  • 00195278201980 ()
5514165

  • Electrode/transducer strap, single-use
No Description
Sibel Health Inc.
900-00062
In Commercial Distribution

  • 00850064210248 ()


  • Wearable multiple physiological parameter recorder, reusable
No Description
Sibel Health Inc.
900-00039
In Commercial Distribution

  • 00850064210200 ()


  • Wearable multiple physiological parameter recorder, reusable
No Description
Sibel Health Inc.
810-00012
In Commercial Distribution

  • 00850064210149 ()


  • Wearable multiple physiological parameter recorder, reusable
Box of 30 7-Day adhesives for the ANNE Chest sensor.
Sibel Health Inc.
900-00010
In Commercial Distribution

  • 00850064210101 ()


  • Wearable multiple vital physiological parameter monitor
Pouch of 10 1-Day adhesives for the ANNE Chest sensor.
Sibel Health Inc.
900-00014
In Commercial Distribution

  • 00850064210026 ()


  • Wearable multiple vital physiological parameter monitor
Pouch of 5 7-Day Adhesives for the ANNE Chest sensor.
Sibel Health Inc.
900-00038
In Commercial Distribution

  • 00850064210019 ()


  • Wearable multiple vital physiological parameter monitor
The ANNE Chest is a wearable, wireless sensor intended for the measurement of ECG waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature.
Sibel Health Inc.
900-00007
In Commercial Distribution

  • 00850064210002 ()


  • Wearable multiple vital physiological parameter monitor
The ANNE Chest is a wearable, wireless sensor intended for the measurement of ECG waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature.
Sibel Health Inc.
810-00012
In Commercial Distribution

  • 00860004541745 ()


  • Wearable multiple vital physiological parameter monitor
No Description
BIOBEAT TECHNOLOGIES LTD
2.1.0
In Commercial Distribution

  • 07290020154309 ()
BB90000200003

  • Multiple physiological parameter spot-check system, clinical
No Description
BIOBEAT TECHNOLOGIES LTD
1.1.0
In Commercial Distribution

  • 07290020154101 ()
BB90000100000

  • Multiple physiological parameter spot-check system, clinical
No Description
BIOBEAT TECHNOLOGIES LTD
2.1.0
In Commercial Distribution

  • 17290020154009 ()
  • 07290020154002 ()
BB90000200040

  • Multiple physiological parameter spot-check system, clinical
No Description
HAPPY HEALTH, INC.
Happy Ring HR1401GB
In Commercial Distribution

  • 00850068747177 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
HAPPY HEALTH, INC.
Happy Ring HR1301GB
In Commercial Distribution

  • 00850068747160 ()


  • Multiple vital physiological parameter monitoring system, home-use
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