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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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Remote Network Station - 00851725007207

No Audio Remote Network Station with Dell OptiPlex 7470 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7470
In Commercial Distribution

  • 00851725007207 ()
RNS-6804-7470

  • Centralized patient monitor

Remote Network Station - 00851725007191

Remote Network Station with Dell OptiPlex 7470 23.8” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7470
In Commercial Distribution

  • 00851725007191 ()
RNS-6803-7470

  • Centralized patient monitor

Remote Network Station - 00851725007184

Remote Network Station with Dell OptiPlex 7460 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7460
In Commercial Distribution

  • 00851725007184 ()
RNS-6803-7460

  • Centralized patient monitor

Remote Network Station - 00851725007177

No Audio Remote Network Station with Dell OptiPlex 7460 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7460
In Commercial Distribution

  • 00851725007177 ()
RNS-6804-7460

  • Centralized patient monitor

N/A - 00851725007160

No Audio Remote Network Station with Dell OptiPlex 24” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7450
In Commercial Distribution

  • 00851725007160 ()
RNS-6804-7450

  • Centralized patient monitor

N/A - 00851725007153

Remote Network Station with Dell OptiPlex 24” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7450
In Commercial Distribution

  • 00851725007153 ()
RNS-6803-7450

  • Centralized patient monitor

N/A - 00851725007146

No Audio Remote Network Station with Dell Inspiron 24” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-3464
In Commercial Distribution

  • 00851725007146 ()
RNS-6804-3464

  • Centralized patient monitor

N/A - 00851725007139

Remote Network Station with Dell Inspiron 24” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-3464
In Commercial Distribution

  • 00851725007139 ()
RNS-6803-3464

  • Centralized patient monitor

Lingraphica - 00850042278116

Speech Generating Device - Dell Venue Android - 10"
Lingraphicare America, Inc.
TouchTalk
In Commercial Distribution

  • 00850042278116 ()


  • Voice synthesizer/digitizer

Lingraphica - 00850042278109

Speech Generating Device - Dell Venue Windows - 10"
Lingraphicare America, Inc.
TouchTalk
In Commercial Distribution

  • 00850042278109 ()


  • Voice synthesizer/digitizer
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