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 AAB01 SpO2 attachment accessory band, PKG of 30 PCS
GE Healthcare Finland Oy
AAB01
In Commercial Distribution

  • 00195278699916 ()
5514165-30

  • Electrode/transducer strap, single-use
Portrait HSWXB Medical Software
GE Healthcare Finland Oy
HSWXB
In Commercial Distribution

  • 00195278697165 ()
5700219-11

  • Physiologic monitor-installed software
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
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
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
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