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
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