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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 View Patient Monitor - 00850064210132

Patient monitor consisting of a mobile tablet and the ANNE View software. The ANNE View Patient Monitor connects to the ANNE Chest sensor, ANNE Limb sensor, and compatible devices for the real-time display of physiological data.
Sibel Health Inc.
900-00012
In Commercial Distribution

  • 00850064210132 ()


  • Wearable multiple vital physiological parameter monitor

7-Day ANNE Chest Adhesive Shelf Box - 00850064210101

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

ANNE Bedside Wireless Charger - 00850064210057

Bedside charger for the ANNE Chest and ANNE Limb sensors.
Sibel Health Inc.
900-00008
In Commercial Distribution

  • 00850064210057 ()


  • Wearable multiple vital physiological parameter monitor

1-Day ANNE Chest Adhesive Pouch - 00850064210026

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

7-Day ANNE Chest Adhesive Pouch - 00850064210019

Pouch of 5 7-Day Adhesives for the ANNE Chest sensor.
Sibel Health Inc.
900-00038
In Commercial Distribution

  • 00850064210019 ()


  • Wearable multiple vital physiological parameter monitor

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

VistaPhone Compact Cardiac Monitoring Kit - 00850490007504

Compact Cardiac Monitoring Kit
Vital Connect, Inc.
1500-01
In Commercial Distribution

  • 00850490007504 ()
1400-02

  • Wearable multiple vital physiological parameter monitoring system

TIMS System - 00850951007265

TIMS Streamer transmits any live medical modality video over networks - LAN, WAN, VPN, and Internet. Provides secure, encrypted and HIPPA Compliant information. Usage includes live training, mentoring, proctoring and monitoring. Functionality includes recording segments and entire procedures.
FORESIGHT IMAGING, LLC
TIMS Streamer 1B
Not in Commercial Distribution

  • 00850951007265 ()
072000-100

  • Medical image management system

TIMS System - 00850951007036

TIMS Streamer transmits any live medical modality video over networks - LAN, WAN, VPN, and Internet. Provides secure, encrypted and HIPPA Compliant information. Usage includes live training, mentoring, proctoring and monitoring. Functionality includes recording segments and entire procedures.
FORESIGHT IMAGING, LLC
TIMS Streamer 1A
Not in Commercial Distribution

  • 00850951007036 ()
072000-100

  • Medical image management system

Central Station - 00851725007399

Central Station is a network device, intended to display, record and print monitored physiological data from Nihon Kohden bedside monitors, telemetry receiver and/or transmitters.
Nihon Kohden Digital Health Solutions, LLC
CNSCS-001
In Commercial Distribution

  • 00851725007399 ()


  • Centralized patient monitor
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