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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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Alarm indicator, cable length
NIHON KOHDEN AMERICA, INC.
YL-612P
In Commercial Distribution

  • 00841983101700 ()
YL-612P

  • Centralized patient monitor
Alarm indicator, cable length
NIHON KOHDEN AMERICA, INC.
YL-611P
In Commercial Distribution

  • 00841983101694 ()
YL-611P

  • Centralized patient monitor
POWER SUPPLY KIT FOR WS-960P
NIHON KOHDEN AMERICA, INC.
SC-611R
In Commercial Distribution

  • 00841983101410 ()
SC-611RA

  • Centralized patient monitor
Central Monitoring Station
NIHON KOHDEN AMERICA, INC.
PU-621R
In Commercial Distribution

  • 00841983101083 ()
PU-621RA

  • Centralized patient monitor
Kosmos Application loaded on an iPad.
ECHONOUS, INC.
iOS 4.X
Not in Commercial Distribution

  • 09353278000823 ()


  • Ultrasound imaging system application software
KOSMOS OTS iOS SOFTWARE PACKAGE [2.X]
ECHONOUS, INC.
P007944
In Commercial Distribution

  • 09353278000762 ()


  • Ultrasound imaging system application software
Kosmos OTS iOS Software Package
ECHONOUS, INC.
P007639
In Commercial Distribution

  • 09353278000717 ()


  • Ultrasound imaging system application software
Kosmos OTS Android Doppler Software Package
ECHONOUS, INC.
P007701
In Commercial Distribution

  • 09353278000700 ()


  • Ultrasound imaging system application software
Kosmos on Android software application for ultrasound imaging
ECHONOUS, INC.
P007465
In Commercial Distribution

  • 09353278000694 ()


  • Ultrasound imaging system application software
Kosmos on Android software application for ultrasound imaging
ECHONOUS, INC.
P007213
In Commercial Distribution

  • 09353278000687 ()


  • Ultrasound imaging system application software
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