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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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NGNK audio, non-touch, multicast
Nihon Kohden Digital Health Solutions, LLC
NGNK-6803-M
In Commercial Distribution

  • 00851725007115 ()
NGNK-6803-M

  • Centralized patient monitor
NetKonnect Option BS-984P (RNS Option)
Nihon Kohden Digital Health Solutions, LLC
BS-984P
In Commercial Distribution

  • 00851725007085 ()
BS-984P

  • Centralized patient monitor
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
NGNK audio, touch, unicast, data storage
Nihon Kohden Digital Health Solutions, LLC
NGNK-6801
Not in Commercial Distribution

  • 00851725007351 ()
NGNK-6801

  • Centralized patient monitor
NGNK no-audio, non-touch, multicast
Nihon Kohden Digital Health Solutions, LLC
NGNK-6804-M
In Commercial Distribution

  • 00851725007337 ()
NGNK-6804-M

  • 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
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