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 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
SENSOR BATTERY DEVICE ASSEMBLY
GE Healthcare Finland Oy
SBT01
In Commercial Distribution

  • 00195278366085 ()
  • 00195278120014 ()
2096442-001

  • Multiple vital physiological parameter monitoring system transceiver
Portrait MMP01 Mobile Patient Monitor Pouch, PKG of 30 PCS
GE Healthcare Finland Oy
MMP01
In Commercial Distribution

  • 00195278110435 ()
5514246

  • Personal device holder, single-use
CHARGER, AMBULATORY CHARGER FINAL DEVICE ASSEMBLY
GE Healthcare Finland Oy
BCH01
In Commercial Distribution

  • 00195278094001 ()
2096439-001

  • Noninvasive device battery charger
HUB, AMBULATORY HUB DEVICE ASSEMBLY
GE Healthcare Finland Oy
HUB01
In Commercial Distribution

  • 00195278093998 ()
2096437-001

  • Wearable multiple vital physiological parameter monitor
Portrait Mobile Patient Monitor Hardware HUBXB
GE Healthcare Finland Oy
HUBXB
In Commercial Distribution

  • 00195278713193 ()
5923524

  • Wearable multiple vital physiological parameter monitor
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