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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 - 00851725007030

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

  • 00851725007030 ()
EDNS-WS24

  • Centralized patient monitor

Prefense - 00851725007023

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

  • 00851725007023 ()
EDNS-9001

  • Centralized patient monitor

NA - 00851725007016

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

NA - 00851725007009

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

Iradimed - 00856038001218

MRI Monitor Remote Base/Charger
IRADIMED CORP.
3885B
In Commercial Distribution

  • 00856038001218 ()
3885B

  • Centralized patient monitor

VIDCO NewtViewer - VIDCO Protocol - 00863067000334

Remote Central Station - Vidco Protocol
VIDCO, INC
MDP2040-0200
In Commercial Distribution

  • 00863067000334 ()


  • Centralized patient monitor

VIDCO MDP - 00863067000327

Remote Viewer and Charting Station for Labor and Delivery Central Station.
VIDCO, INC
MDP2040-0600RV
In Commercial Distribution

  • 00863067000327 ()


  • Centralized patient monitor

VIDCO MDP - 00863067000310

Labor and Delivery Central Station
VIDCO, INC
MDP2020-0600
In Commercial Distribution

  • 00863067000310 ()


  • Centralized patient monitor

VIDCO NetViewer - 00863067000303

Remote Central Station
VIDCO, INC
MDP2040-0100
In Commercial Distribution

  • 00863067000303 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612915857

No Description
FUKUDA DENSHI CO.,LTD.
DS-1812RE
In Commercial Distribution

  • 04538612915857 ()


  • Centralized patient monitor
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