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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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Prefense 24" display
Nihon Kohden Digital Health Solutions, LLC
EDNS-WS24
In Commercial Distribution

  • 00851725007030 ()
EDNS-WS24

  • Centralized patient monitor
Prefense - Early Detection and Notification System (PC)
Nihon Kohden Digital Health Solutions, LLC
EDNS-9001
In Commercial Distribution

  • 00851725007023 ()
EDNS-9001

  • Centralized patient monitor
Remote Network Station with 24” display
Nihon Kohden Digital Health Solutions, LLC
RNS-9703-024
In Commercial Distribution

  • 00851725007016 ()
RNS-9703-024

  • Centralized patient monitor
Remote Network Station with 19” display
Nihon Kohden Digital Health Solutions, LLC
RNS-9703-019
In Commercial Distribution

  • 00851725007009 ()
RNS-9703-019

  • Centralized patient monitor
No Description
Sibel Health Inc.
900-00043
In Commercial Distribution

  • 00850064210262 ()


  • Wearable multiple vital physiological parameter monitor
No Description
Sibel Health Inc.
900-00046
In Commercial Distribution

  • 00850064210224 ()


  • Wearable multiple vital physiological parameter monitor
Central Hub Speaker
Sibel Health Inc.
900-00004
In Commercial Distribution

  • 00850064210194 ()


  • Wearable multiple vital physiological parameter monitor
Central Hub CMS
Sibel Health Inc.
900-00013
In Commercial Distribution

  • 00850064210163 ()


  • Wearable multiple vital physiological parameter monitor
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
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
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