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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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EnSite™ - 05415067037749

X EP System LiveView Dynamic Display Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-LV-01
In Commercial Distribution

  • 05415067037749 ()
ENSITE-D-LV-01

  • Cardiac mapping system application software

HolterCare Editing Kit - 00856298006268

License dongle for second workstation using the HolterCare software.
SCOTTCARE CORPORATION, THE
HolterCare Editing Kit
In Commercial Distribution

  • 00856298006268 ()
100080

  • Electrocardiographic long-term ambulatory recording analyser application software

ACPlus Respiratory Assessment - 00858703006344

Software and sensor to provide assessment of respiratory capabilities.
ACCELERATED CARE PLUS CORP
ARASoftware
In Commercial Distribution

  • 00858703006344 ()


  • Pulmonary function analysis software, interpretive
  • Diagnostic spirometer, professional

Eko Mobile App iOS - 00863609000334

iOS mobile device software for use with Eko products.
Eko Devices, Inc.
3.1.1
In Commercial Distribution

  • 00863609000334 ()


  • Medical equipment clinical data interfacing software

REMI - 00860011072447

REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Use Module
Epitel, Inc.
2.x.x.x
In Commercial Distribution

  • 00860011072447 ()
20016

  • Electroencephalographic monitoring system

REMI - 00860011072416

REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Startup Module
Epitel, Inc.
2.x.x.x
In Commercial Distribution

  • 00860011072416 ()
20016

  • Electroencephalographic monitoring system

LiDCO - 05060110523030

Licence, Software, LiDCOrapid (Rapid, CNAP, BIS, Ext), Six Month
LIDCO LIMITED
Li11076H
In Commercial Distribution

  • 05060110523030 ()
Li11076H

  • General-purpose multi-parameter bedside monitor

TrakStar Patient Data Management System Software - 00850005944553

Cloud version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.8 (Cloud)
In Commercial Distribution

  • 00850005944553 ()
83-00090-000

  • Magnetic neural stimulation system

TrakStar Patient Data Management System Software - 00850005944447

Local version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.8 (Local)
In Commercial Distribution

  • 00850005944447 ()
83-00091-000

  • Magnetic neural stimulation system

TrakStar Patient Data Management System Software - 00850005944133

Cloud version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.6 (Cloud)
In Commercial Distribution

  • 00850005944133 ()
83-00060-000

  • Magnetic neural stimulation system
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