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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CHARGER, AMBULATORY CHARGER FINAL DEVICE ASSEMBLY
GE Healthcare Finland Oy
BCH01
In Commercial Distribution

  • 00195278094001 ()
2096439-001

  • Noninvasive device battery charger
PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.1.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CSSXB
In Commercial Distribution

  • 00195278659446 ()
5933539

  • Bedside information system application software
Portrait Central Viewer Application Installer v1.1.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVAXB
In Commercial Distribution

  • 00195278656681 ()
5863721-11

  • Wireless patient monitor/sensor reporting software, professional-only
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
HUB, AMBULATORY HUB DEVICE ASSEMBLY
GE Healthcare Finland Oy
HUB01
In Commercial Distribution

  • 00195278093998 ()
2096437-001

  • 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
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
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