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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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Vital Sync - 10884521815810

Vital Sync Mobile Application Software
Covidien LP
VSMOBILEAPPSW01
In Commercial Distribution

  • 10884521815810 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

IH-Com V5.2 - 03610522123919

IH-Com V5.2, Software Version 5.2
Bio-Rad Medical Diagnostics GmbH
5.2
In Commercial Distribution

  • 03610522123919 ()
12010236

  • Laboratory instrument/analyser application software IVD

AVEA - 10846446000979

KIT,AVEA UPGRADE UIM & SOFTWARE
Carefusion Corporation
12285
Not in Commercial Distribution

  • 10846446000979 ()


  • Ventilator application software

AVEA - 10846446064872

KIT,AVEA UPGRADE GDE & SOFTWARE
Carefusion Corporation
12284-PMN
Not in Commercial Distribution

  • 10846446064872 ()
12284-PMN

  • Ventilator application software

Somnostar - 10846446032260

SOFTWARE KIT LABMANAGER SQL PATCH
Carefusion Corporation
63783
Not in Commercial Distribution

  • 10846446032260 ()
63783

  • Home-use sleep apnoea recording system

Vela - 10846446012705

KIT,ET-CO2 MODULE W/SOFTWARE
Carefusion Corporation
16920
Not in Commercial Distribution

  • 10846446012705 ()
16920

  • Carbon dioxide sensor/cable

IEM GmbH - 04041346102207

Hypertension Management Software Version 6
IEM GmbH
HMS CS 6.3.x
In Commercial Distribution

  • 04041346102207 ()


  • Medical equipment clinical data interfacing software

IEM GmbH - 04041346102153

Hypertension Management Software Version 6
IEM GmbH
HMS CS 6.2.x
Not in Commercial Distribution

  • 04041346102153 ()


  • Medical equipment clinical data interfacing software

IEM GmbH - 04041346100876

Hypertension Management Software Version 6
IEM GmbH
HMS CS 6.1.3
In Commercial Distribution

  • 04041346100876 ()


  • Medical equipment clinical data interfacing software

VITEK®2 - 03573026609399

CD WITH 9.02 software version
BIOMERIEUX , INC.
9.02.0
In Commercial Distribution

  • 03573026609399 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated

NUCLISENS® easyMAG® SOFTWARE V2. 1 - 03573026448301

EASYMAG SOFTWARE V2.1 : virtual reference
BIOMERIEUX SA
2.1
In Commercial Distribution

  • 03573026448301 ()


  • Nucleic acid sample preparation instrument IVD

CRW® - 10381780252634

ImageFusion 3 Software Install Kit
INTEGRA LIFESCIENCES CORPORATION
IF3000
Not in Commercial Distribution

  • M433IF30001 ()
  • 10381780252634 ()


  • Stereotactic radiosurgical invasive head frame

Integra® NeuroSight® - 10381780252627

NeuroSight Arc Software on Laptop
INTEGRA LIFESCIENCES CORPORATION
ST1000
Not in Commercial Distribution

  • M433ST10001 ()
  • 10381780252627 ()
ST1000

  • Neurological stereotactic surgery system

Monarch™ Software Tower v2.1.2 - B634SW0032740201020

Monarch™ Software Tower v2.1.2
AURIS HEALTH, INC.
Version 2.1.2
In Commercial Distribution

  • B634SW0032740201020 ()


  • Robotic surgical system application software

Monarch™ Software Laptop v2.1.5 - B634SW0032760201050

Monarch™ Software Laptop v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution

  • B634SW0032760201050 ()


  • CT system application software

Monarch™ Software Laptop v2.1.4 - B634SW0032760201040

Monarch™ Software Laptop v2.1.4
AURIS HEALTH, INC.
Version 2.1.4
In Commercial Distribution

  • B634SW0032760201040 ()


  • CT system application software

Monarch™ Software Laptop v2.1.3 - B634SW0032760201030

Monarch™ Software Laptop v2.1.3
AURIS HEALTH, INC.
Version 2.1.3
In Commercial Distribution

  • B634SW0032760201030 ()


  • CT system application software

Monarch™ Software Laptop v2.1.2 - B634SW0032760201020

Monarch™ Software Laptop v2.1.2
AURIS HEALTH, INC.
Version 2.1.2
In Commercial Distribution

  • B634SW0032760201020 ()


  • CT system application software

Monarch™ Software Cart v2.1.5 - B634SW0032750201050

Monarch™ Software Cart v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution

  • B634SW0032750201050 ()


  • Robotic surgical system application software

Monarch™ Software Cart v2.1.4 - B634SW0032750201040

Monarch™ Software Cart v2.1.4
AURIS HEALTH, INC.
Version 2.1.4
In Commercial Distribution

  • B634SW0032750201040 ()


  • Robotic surgical system application software

Monarch™ Software Cart v2.1.3 - B634SW0032750201030

Monarch™ Software Cart v2.1.3
AURIS HEALTH, INC.
Version 2.1.3
In Commercial Distribution

  • B634SW0032750201030 ()


  • Robotic surgical system application software

Monarch™ Software Cart v2.1.2 - B634SW0032750201020

Monarch™ Software Cart v2.1.2
AURIS HEALTH, INC.
Version 2.1.2
In Commercial Distribution

  • B634SW0032750201020 ()


  • Robotic surgical system application software

Monarch™ Software Tower v2.1.5 - B634SW0032740201050

Monarch™ Software Tower v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution

  • B634SW0032740201050 ()


  • Robotic surgical system application software

Monarch™ Software Tower v2.1.4 - B634SW0032740201040

Monarch™ Software Tower v2.1.4
AURIS HEALTH, INC.
Version 2.1.4
In Commercial Distribution

  • B634SW0032740201040 ()


  • Robotic surgical system application software

Monarch™ Software Tower v2.1.3 - B634SW0032740201030

Monarch™ Software Tower v2.1.3
AURIS HEALTH, INC.
Version 2.1.3
In Commercial Distribution

  • B634SW0032740201030 ()


  • Robotic surgical system application software

Welch Allyn, Inc. - 00817655020952

Hscribe Web Upload software kit
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00817655020952 ()
88188-001-50

  • Centralized patient monitor

Welch Allyn, Inc. - 00817655023106

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

  • 00817655023106 ()
419734

  • Centralized patient monitor

Welch Allyn, Inc. - 00817655021294

DVD SOFTWARE XScribe CP v4.0.3
WELCH ALLYN, INC.
901144
Not in Commercial Distribution

  • 00817655021294 ()
420181

  • Electrocardiographic lead set, reusable

EchoInsight - B557ECHOINSIGHT0

Software for analysis of echocardiogram
EPSILON IMAGING
3.2.0
Not in Commercial Distribution

  • B557ECHOINSIGHT0 ()


  • Cardiac mapping system application software

PULSOX-300i - 00817770020547

Oximeter Sleep Study without Software
MAXTEC, LLC
R204P18-001
Not in Commercial Distribution

  • 00817770020547 ()


  • Pulse oximeter

Arthrex® - 00888867384866

Synergy Matrix Core Software License
ARTHREX, INC.
AR-3200-1053
In Commercial Distribution

  • 00888867384866 ()
AR-3200-1053

  • Multidisciplinary medical image management software

Diversatek Healthcare - 00816734023488

Desktop PC with Zvu Software
DIVERSATEK HEALTHCARE, INC.
COMP-KIT
In Commercial Distribution

  • 00816734023488 ()
COMP-KIT

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734022825

ZVU® Functional GI Software
DIVERSATEK HEALTHCARE, INC.
ZVU-3
In Commercial Distribution

  • 00816734022825 ()
ZVU-3

  • Manometric gastrointestinal motility analysis system

Bioview - 00816734022139

Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-7P1
In Commercial Distribution

  • 00816734022139 ()
  • B019S9819257P10 ()
S98-1925-7P1

  • Manometric gastrointestinal motility analysis system

Bioview - 00816734022122

Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-6P1
In Commercial Distribution

  • 00816734022122 ()
  • B019S9819256P10 ()
S98-1925-6P1

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022115

Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-5P1
In Commercial Distribution

  • 00816734022115 ()
  • B019S9819255P10 ()
S98-1925-5P1

  • Manometric gastrointestinal motility analysis system

X-Guide - 00817421022920

X-Guide 3.6.0 Linux Software (MDR)
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022920 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020803

X-Guide Windows Planning Software 2.3.3
XNAV TECHNOLOGIES LLC
P008296
In Commercial Distribution

  • 00817421020803 ()
P008296

  • Dental treatment application software

X-GUIDE - 00817421020797

X-Guide System Software Version 2.3.0
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421020797 ()
P008542

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020018

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

  • 00817421020018 ()
P008526

  • Surgical planning/navigation-enhancement system
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