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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™ - 05415067037770

X EP System Omnipolar Technology Data Export Software License
ST. JUDE MEDICAL, INC.
ENSITE-OTEXPORT-01
In Commercial Distribution

  • 05415067037770 ()
ENSITE-OTEXPORT-01

  • Cardiac mapping system application software

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

EnSite™ - 05415067046659

X EP System TactiFlex Ablation Catheter, SE Software License
ST. JUDE MEDICAL, INC.
ENSITE-TF-02
In Commercial Distribution

  • 05415067046659 ()
ENSITE-TF-02

  • Cardiac mapping system application software

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

REMI - 00860005388172

REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Use Module
Epitel, Inc.
1.x.x.x
Not in Commercial Distribution

  • 00860005388172 ()


  • Electroencephalographic monitoring system

BD Pyxis - 10885403513800

BD Pyxis MedBank Tower (Cabinet CR Software v3.X)
CAREFUSION 303, INC.
SW-MB-CR-V3
In Commercial Distribution

  • 10885403513800 ()


  • Anaesthesia cabinet

Philips Sonicare - 08710103988984

Software, Sonicare Power Tooth brush, Web download App Android
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988984 ()


  • Basic electric toothbrush

Philips Sonicare - 08710103988977

Software, Sonicare Power Tooth brush, Web download App iOS
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988977 ()


  • Basic electric toothbrush

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

TrakStar Patient Data Management System Software - 00850005944126

Cloud version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.5 (Cloud)
In Commercial Distribution

  • 00850005944126 ()
83-00060-000

  • Magnetic neural stimulation system

TrakStar Patient Data Management System Software - 00850005944102

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

  • 00850005944102 ()
83-00056-000

  • Magnetic neural stimulation system

TrakStar Patient Data Management System Software - 00850005944096

Local version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.5 (Local)
In Commercial Distribution

  • 00850005944096 ()
83-00056-000

  • Magnetic neural stimulation system

Care Orchestrator Essence - 00606959062863

Care Orchestrator Essence, Medical equipment clinical data interfacing software
Respironics, Inc.
4.0.0
In Commercial Distribution

  • 00606959062863 ()
1135709

  • Medical equipment clinical data interfacing software

Natus - 00382830045087

EMG v20/v21 to Natus Elite v2 Software Upgrade
NATUS NEUROLOGY INCORPORATED
688-630400
In Commercial Distribution

  • 00382830045087 ()


  • Electromyograph

Natus - 00382830062251

Natus Elite v2 Software Upgrade with New System Order
NATUS NEUROLOGY INCORPORATED
688-630200
In Commercial Distribution

  • 00382830062251 ()


  • Electromyograph

Task Force® Monitor Software - 09120073931931

Task Force® Monitor software incl. customer CD (multilingual)
CNSystems Medizintechnik GmbH
V2.3
In Commercial Distribution

  • 09120073931931 ()
FHCS3043

  • General-purpose multi-parameter bedside monitor

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

AngioDynamics - H7877001059370

Software Module (RoHS Compliant) RITA Model 1500X RF Generator
ANGIODYNAMICS, INC.
700-105937
In Commercial Distribution

  • H7877001059370 ()
  • 15051684025867 ()


  • Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar

AngioDynamics - H7877001057400

Japanese Software Module for RITA Model 1500X RF Generator
ANGIODYNAMICS, INC.
700-105740
Not in Commercial Distribution

  • H7877001057400 ()
  • 15051684026253 ()


  • Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar

SICAT Function - D77664556410

Radiological visualization software for diagnosis and dental treatment planning
SiCAT GmbH & Co. KG
6455641
Not in Commercial Distribution

  • D77664556410 ()
6455641

  • Diagnostic x-ray digital imaging system workstation

Vasomedical™ EZ™ Software CD & Data Cable for ECG Monitor - 00817980021396

EZ™ Software CD & Data Cable for ECG Monitor
VASOMEDICAL, INC.
Model EZ
In Commercial Distribution

  • 00817980021396 ()
A13-0040

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ ARCS Analysis & Reporting S/W Dongle Only, 12 CH ECG - 00817980020221

ARCS Analysis & Reporting Software Dongle Only, 12 Channel ECG
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020221 ()
A10-0118-12

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ ARCS Analysis & Reporting S/w & Dongle, 12 CH ECG, USB - 00817980020214

ARCS Analysis & Reporting Software & Dongle, 12 Channel ECG, USB
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020214 ()
A10-0118-10

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ ARCS Analysis & Reporting Software Dongle Only, 3 CH ECG - 00817980020207

ARCS Analysis & Reporting Software Dongle Only, 3 Channel ECG
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020207 ()
A10-0118-02

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ ARCS Analysis & Reporting S/W & Dongle, 3 CH ECG, USB - 00817980020177

ARCS Analysis & Reporting Software & Dongle, 3 Channel ECG, USB
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020177 ()
A10-0118-00

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ CB Series Analysis & Reporting Software - 3 & 12 CH ECG - 00817980020139

CB Series Analysis & Reporting Software - 3 & 12 CH ECG
VASOMEDICAL, INC.
CB Series S/W
In Commercial Distribution

  • 00817980020139 ()
A10-0031

  • Electrocardiographic long-term ambulatory recording analyser application software

SOZOpro - B277SOZOPRO0

Application- Bio-Impendence Analysis software used for determining Body Composition
IMPEDIMED LIMITED
1.1.0
Not in Commercial Distribution

  • B277SOZOPRO0 ()
SOZOpro

  • Bioelectrical body composition analyser

Synergy E - B036101483

Synergy E Host Software for SmartMonitor 2 Product Line
CIRCADIANCE, LLC
101483
In Commercial Distribution

  • B036101483 ()
101483

  • Infant apnoea monitor

MicronMapper - 07540209956232

Software for MicronMapper and MicronMapper EVO Dental Metrology Systems
Claronav Inc
990-MM1-INST-WIN
In Commercial Distribution

  • 07540209956232 ()


  • Dental milling system, CAD/CAM, laboratory

Ivenix Infusion System - 00811505030467

Large Volume Pump (LVP) Software (order 1 per pump)
Fresenius Kabi AG
030-0028-08
In Commercial Distribution

  • 00811505030467 ()
LVP-SW

  • Bedside infusion pump, single-channel

Ivenix Infusion System - 00811505030436

Large Volume Pump (LVP) Software (order 1 per pump)
Fresenius Kabi AG
030-0028-07
In Commercial Distribution

  • 00811505030436 ()
LVP-SW

  • Bedside infusion pump, single-channel

Ivenix Infusion System - 00811505030375

Large Volume Pump (LVP) Software (order 1 per pump)
Fresenius Kabi AG
030-0028-06
In Commercial Distribution

  • 00811505030375 ()
LVP-SW

  • Bedside infusion pump, single-channel

Ivenix Infusion System - 00811050530375

Large Volume Pump (LVP) Software (order 1 per pump)
Fresenius Kabi AG
030-0028-06
Not in Commercial Distribution

  • 00811050530375 ()
LVP-SW

  • Bedside infusion pump, single-channel

Sherlock - 00801741121470

Sherlock 3GC Diamond TCS on Site~Rite 8 Software
Bard Access Systems, Inc.
Sherlockv1.1.2
In Commercial Distribution

  • 00801741121470 ()
Sherlockv1.1.2

  • Central venous catheter navigation system, electrocardiographic/magnetic

Bausch + Lomb - 00757770524532

Stellaris Elite PC with Laser with Version 5+ Software
Bausch & Lomb Incorporated
BL15455
In Commercial Distribution

  • 00757770524532 ()
BL15455

  • Phacoemulsification/vitrectomy system

Bausch + Lomb - 00757770524525

Stellairs Elite PC Combined System with Version 5+ Software
Bausch & Lomb Incorporated
BL14455
In Commercial Distribution

  • 00757770524525 ()
BL14455

  • Phacoemulsification/vitrectomy system

TomoTherapy® Treatment Delivery System - M65810489680

Software, TomoApps, Version 2.1.1, Build # 5.1.1 (Operating Software for TomoTherapy systems, including TomoH®, TomoHD®, TomoHDA™ and Onrad™)
ACCURAY INCORPORATED
1048968
In Commercial Distribution

  • M65810489680 ()
N/A

  • Linear accelerator system

Norav 1200 Series PC-ECG - 07290110252540

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - ECG Management System NEMS, Cloud Access to NEMS-Q The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NEMS-CL
In Commercial Distribution

  • 07290110252540 ()
HASP-SW-K-NEMS-CL-01

  • Patient-administration information system application software
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