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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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ResScan - 00619498313020

Patient data management software (web version)
RESMED PTY LTD
31302
In Commercial Distribution

  • 00619498313020 ()
31302

  • Ventilator application software

ResScan - 00619498000722

Patient data management software (web version)
RESMED PTY LTD
31302
In Commercial Distribution

  • 00619498000722 ()
31302

  • Ventilator application software

OMNIBotics - 00841690194521

Knee Software Package, ART 2.1 Add-on
Omni Life Science, Inc.
NS-27008
In Commercial Distribution

  • 00841690194521 ()
NS-27008

  • Instrument tray, reusable

OMNIBotics - 00841690194507

Knee Software Package, ART 2.3 Add-on
Omni Life Science, Inc.
NS-27010
In Commercial Distribution

  • 00841690194507 ()
NS-27010

  • Instrument tray, reusable

Portrait CSS01 - 00195278341129

PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.0.3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CSS01
In Commercial Distribution

  • 00195278341129 ()
5870857

  • Bedside information system application software

Portrait CVA01 - 00195278330413

PORTRAIT CENTRAL STATION INSTALLATION SOFTWARE V1.0.2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVA01
In Commercial Distribution

  • 00195278330413 ()
5863721

  • Wireless patient monitor/sensor reporting software, professional-only

Portrait CSSXB - 00195278659446

PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.1.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CSSXB
In Commercial Distribution

  • 00195278659446 ()
5933539

  • Bedside information system application software

not applicable - 00195278719812

Software Pristina ME 9.2 - ISO file
GE MEDICAL SYSTEMS
PRISTINA ME 9.2
In Commercial Distribution

  • 00195278719812 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital

PULSE - 00195377099013

PULSE Software Package including IOM, iG
Nuvasive, Inc.
8000104
In Commercial Distribution

  • 00195377099013 ()


  • Orthopaedic stereotactic surgery system

OMNIBotics - 00841690194538

Knee Software Package, ART 2.0.1 Add-on
Omni Life Science, Inc.
NS-27007
In Commercial Distribution

  • 00841690194538 ()
NS-27007

  • Instrument tray, reusable
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