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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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QTEL v5.0.1 eSIGNATURE SOFTWARE CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00817655023106 ()
419734

  • Centralized patient monitor
Oximeter Sleep Study without Software
MAXTEC, LLC
R204P18-001
Not in Commercial Distribution

  • 00817770020547 ()


  • Pulse oximeter
X-GUIDE PLANNING SOFTWARE - MAC OS
XNAV TECHNOLOGIES LLC
P008526
In Commercial Distribution

  • 00817421020018 ()
P008526

  • Surgical planning/navigation-enhancement system
X-GUIDE PLANNING SOFTWARE - MS WINDOWS
XNAV TECHNOLOGIES LLC
P008296
In Commercial Distribution

  • 00817421020001 ()
P008296

  • Surgical planning/navigation-enhancement system
KIT,ET-CO2 MODULE W/SOFTWARE
Carefusion Corporation
16920
Not in Commercial Distribution

  • 10846446012705 ()
16920

  • Carbon dioxide sensor/cable
SOFTWARE KIT LABMANAGER SQL PATCH
Carefusion Corporation
63783
Not in Commercial Distribution

  • 10846446032260 ()
63783

  • Home-use sleep apnoea recording system
KIT,AVEA UPGRADE GDE & SOFTWARE
Carefusion Corporation
12284-PMN
Not in Commercial Distribution

  • 10846446064872 ()
12284-PMN

  • Ventilator application software
Software Medical Device INW V7.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
A1
Not in Commercial Distribution

  • 00840682145756 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
Hypertension Management Software Version 6
IEM GmbH
HMS CS 6.3.x
In Commercial Distribution

  • 04041346102207 ()


  • Medical equipment clinical data interfacing software
Hypertension Management Software Version 6
IEM GmbH
HMS CS 6.2.x
Not in Commercial Distribution

  • 04041346102153 ()


  • Medical equipment clinical data interfacing software
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