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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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ANNE Chest Sensor Kit - 00850064210002

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

ExSpiron 1Xi - 00851540007055

Assembly designed to be integrated into medical facility infrastructure in order to trigger a nurse call alarm system. Designed to be used only with the ExSpiron 1Xi Monitor.
Respiratory Motion Inc.
Nurse Call Module
In Commercial Distribution

  • 00851540007055 ()
  • 00851540007079 ()
RMI-51155

  • Nurse call system

PatientCare Link - 00852132007316

Upload and transmission software application
PREVENTICE TECHNOLOGIES, INC.
SW1004
In Commercial Distribution

  • 00852132007316 ()


  • Cardiopulmonary physiological parameter analysis software

ECG Plug-In - 00852132007309

Monitor communication software application
PREVENTICE TECHNOLOGIES, INC.
SW1003
In Commercial Distribution

  • 00852132007309 ()


  • Cardiopulmonary physiological parameter analysis software

BodyGuardian Connect - 00852132007293

Transmission software application
PREVENTICE TECHNOLOGIES, INC.
SW1002
In Commercial Distribution

  • 00852132007293 ()


  • Cardiopulmonary physiological parameter analysis software

PatientCare Platform - 00852132007286

Platform software application for data collection and analysis
PREVENTICE TECHNOLOGIES, INC.
SW1001
In Commercial Distribution

  • 00852132007286 ()


  • Cardiopulmonary physiological parameter analysis software

M&B - 06922649905055

No Description
Beijing M&B Electronic Instruments Co., Ltd.
MSA100BT
In Commercial Distribution

  • 06922649905055 ()


  • Expiratory peak flow meter, digital

M&B - 06922649905048

No Description
Beijing M&B Electronic Instruments Co., Ltd.
MSA100
In Commercial Distribution

  • 06922649905048 ()


  • Expiratory peak flow meter, digital

BOTHEALTH - 06920485305015

No Description
Shenzhen BSX Technology Electronics Co., Ltd.
BSX501
In Commercial Distribution

  • 06920485305015 ()


  • Patient monitoring system module, blood pressure, noninvasive

BOTHEALTH - 06920485305954

No Description
Shenzhen BSX Technology Electronics Co., Ltd.
BSX595
In Commercial Distribution

  • 06920485305954 ()


  • Patient monitoring system module, blood pressure, noninvasive
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