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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

CARESCAPE - 00840682109833

CARESCAPE CENTRAL STATION V1 UPGRADE KIT FROM CIC V5 ON MP100
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Central Station v1 upgrade
Not in Commercial Distribution

  • 00840682109833 ()


  • Centralized patient monitor

CARESCAPE - 00840682109826

ASSY CSCS V1 MP100D DESKTOP
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Central Station v1
Not in Commercial Distribution

  • 00840682109826 ()


  • Centralized patient monitor

CARESCAPE Central Station - 00840682109666

CARESCAPE CENTRAL STATION V2 MAI 700 ATO MODEL
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V2 Integrated MAI 700
Not in Commercial Distribution

  • 00840682109666 ()


  • Centralized patient monitor

CARESCAPE Central Station - 00840682109604

CARESCAPE CENTRAL STATION V2 MAS 700 ATO MODEL
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V2 Standard MAS 700
Not in Commercial Distribution

  • 00840682109604 ()


  • Centralized patient monitor

Mobile Care - 00840682106498

No Description
GE Healthcare Finland Oy
Web Viewer
In Commercial Distribution

  • 00840682106498 ()


  • Centralized patient monitor

Xhibit - 10841522131141

DISPLAY,21.5",CAPACITIVE TOUCH,BLACK,ANTI-GLARE
SPACELABS HEALTHCARE (WASHINGTON), INC
Exhibit Central
In Commercial Distribution

  • 10841522131141 ()

  • 21.5"
011-0262-00

  • Centralized patient monitor
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