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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™ - 05415067000026

GenConnect Module Generator Connector
ST. JUDE MEDICAL, INC.
H00002
In Commercial Distribution

  • 05415067000026 ()
H00002

  • Electrical-only medical device connection cable, reusable

ECGenius System - 05700002168535

The ECGenius™ System is an electrophysiology measurement system and analysis tool used to acquire, filter, digitize, amplify, display, record, and analyze data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart. The PVI Analyzer™ feature is a secondary measure of pulmonary vein isolation and should not replace traditional methods of confirming isolation.
Cathvision ApS
CVT-0069 R3.0
Not in Commercial Distribution

  • 05700002168535 ()
CVT-0069 R3.0 ECGenius System

  • Cardiac electrophysiology analysis system

ECGenius System - 05700002168528

The ECGenius System is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.The ECGenius System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record clinical data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
Cathvision ApS
CVT-0069 R2.0
Not in Commercial Distribution

  • 05700002168528 ()
CVT-0069 R2.0 ECGenius System

  • Cardiac electrophysiology analysis system

EnSite™ - 05415067053145

X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-03
In Commercial Distribution

  • 05415067053145 ()
ENSITE-D-FWV-03

  • Cardiac mapping system application software

EnSite™ - 05415067053138

X EP System PFA Catheter Visualization Software License
ST. JUDE MEDICAL, INC.
ENSITE-FWV-03
In Commercial Distribution

  • 05415067053138 ()
ENSITE-FWV-03

  • Cardiac mapping system application software

EnSite™ - 05415067053121

X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-3.1.1
In Commercial Distribution

  • 05415067053121 ()
ENSITE-SW-3.1.1

  • Cardiac mapping system application software

EnSite™ - 05415067051165

X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-3.1
In Commercial Distribution

  • 05415067051165 ()
ENSITE-SYSTEM-3.1

  • Cardiac mapping system

EnSite™ - 05415067051141

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-3.1
In Commercial Distribution

  • 05415067051141 ()
ENSITE-R-DWS-3.1

  • Cardiac mapping system

EnSite™ - 05415067051134

X EP System
ST. JUDE MEDICAL, INC.
ENSITE-R-SYS-3.1
In Commercial Distribution

  • 05415067051134 ()
ENSITE-R-SYS-3.1

  • Cardiac mapping system

EnSite™ - 05415067051127

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-3.1
In Commercial Distribution

  • 05415067051127 ()
ENSITE-DWS-3.1

  • Cardiac mapping system

EnSite™ - 05415067051110

X EP System PFA Catheter Visualization Software License
ST. JUDE MEDICAL, INC.
ENSITE-FWV-02
In Commercial Distribution

  • 05415067051110 ()
ENSITE-FWV-02

  • Cardiac mapping system application software

EnSite™ - 05415067051103

X EP System Advisor HD Grid X Mapping Catheter, Sensor Enabled Software License
ST. JUDE MEDICAL, INC.
ENSITE-HDGX-01
In Commercial Distribution

  • 05415067051103 ()
ENSITE-HDGX-01

  • Cardiac mapping system application software

EnSite™ - 05415067051097

X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-02
In Commercial Distribution

  • 05415067051097 ()
ENSITE-D-FWV-02

  • Cardiac mapping system application software

EnSite™ - 05415067050298

X EP System PFA Catheter Visualization Software License
ST. JUDE MEDICAL, INC.
ENSITE-FWV-01
In Commercial Distribution

  • 05415067050298 ()
ENSITE-FWV-01

  • Cardiac mapping system application software

EnSite™ - 05415067050281

X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-01
In Commercial Distribution

  • 05415067050281 ()
ENSITE-D-FWV-01

  • Cardiac mapping system application software

EnSite™ - 05415067050021

X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-3.0.2
In Commercial Distribution

  • 05415067050021 ()
ENSITE-TFM-3.0.2

  • Cardiac mapping system application software

EnSite™ - 05415067050014

X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-3.0.2
In Commercial Distribution

  • 05415067050014 ()
ENSITE-SW-3.0.2

  • Cardiac mapping system application software

EnSite™ - 05415067049988

X EP System OTA Certificate Software License
ST. JUDE MEDICAL, INC.
ENSITE-OTAC-02
In Commercial Distribution

  • 05415067049988 ()
ENSITE-OTAC-02

  • Cardiac mapping system application software

EnSite™ - 05415067049711

X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-3.1
In Commercial Distribution

  • 05415067049711 ()
ENSITE-TFM-3.1

  • Cardiac mapping system application software

EnSite™ - 05415067049704

X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-3.1
In Commercial Distribution

  • 05415067049704 ()
ENSITE-SW-3.1

  • Cardiac mapping system application software

STAR Apollo - 00860009793521

The STAR Apollo Mapping System is a cardiac mapping method that is based on proprietary algorithms developed to identify localized sources of atrial activation during AF. The STAR Apollo Mapping System does not aim to elucidate the mechanism of AF, rather it seeks to reveal the anatomical location of regions where activation may be originating from, regardless of mechanism. This is based on a very simple and fundamental principle that the source of activation will have activation emerging from it in multiple directions, but not progressing towards it.
Rhythm AI Inc.
STAR Apollo Mapping System
In Commercial Distribution

STAR Apollo Mapping System

  • Cardiac mapping system application software

STAR Apollo - 00860009793507

The STAR Apollo Mapping System is a cardiac mapping method that is based on proprietary algorithms developed to identify localized sources of atrial activation during AF. The STAR Apollo Mapping System does not aim to elucidate the mechanism of AF, rather it seeks to reveal the anatomical location of regions where activation may be originating from, regardless of mechanism. This is based on a very simple and fundamental principle that the source of activation will have activation emerging from it in multiple directions, but not progressing towards it.
Rhythm AI Inc.
STAR Apollo Mapping System
Not in Commercial Distribution

  • 00860009793507 ()
STAR Apollo Mapping System

  • Cardiac mapping system application software

CardioInsight™ - 00643169723689

SENSOR ARRAY VEST CITVST0004XL US
MEDTRONIC, INC.
CITVST0004XL
In Commercial Distribution

  • 00643169723689 ()


  • Cardiac mapping system electrode array

CardioInsight™ - 00643169723672

SENSOR ARRAY VEST CITVST0003L US
MEDTRONIC, INC.
CITVST0003L
In Commercial Distribution

  • 00643169723672 ()


  • Cardiac mapping system electrode array

CardioInsight™ - 00643169723665

SENSOR ARRAY VEST CITVST0002M US
MEDTRONIC, INC.
CITVST0002M
Not in Commercial Distribution

  • 00643169723665 ()


  • Cardiac mapping system electrode array

CardioInsight™ - 00643169723658

SENSOR ARRAY VEST CITVST0001S US
MEDTRONIC, INC.
CITVST0001S
In Commercial Distribution

  • 00643169723658 ()


  • Cardiac mapping system electrode array

CardioInsight™ - 00643169723603

MAPPING SYSTEM CIT200 CIT US
MEDTRONIC, INC.
CIT200
In Commercial Distribution

  • 00643169723603 ()


  • Cardiac mapping system

Welch Allyn, Inc. - 00732094261332

UPGRADE KIT FOR HEARTCENTRIX
WELCH ALLYN, INC.
901152
In Commercial Distribution

  • 00732094261332 ()
UPGHC-B-SW-A

  • Patient health record information system application software

Welch Allyn, Inc. - 00732094335866

HEARTCENTRIX v7.1.0 FIXPACK INSTAL KIT
WELCH ALLYN, INC.
901152
In Commercial Distribution

  • 00732094335866 ()
H50-71A

  • Patient health record information system application software

Welch Allyn, Inc. - 00732094315318

HSCRIBE TO PYRAMIS INTERFACE
WELCH ALLYN, INC.
901012
In Commercial Distribution

  • 00732094315318 ()
11095-002-70

  • Patient health record information system application software

Welch Allyn, Inc. - 00732094272338

SFTW PYRAMIS IE9 10 UPGRADE V6.2 6.5
WELCH ALLYN, INC.
901152
In Commercial Distribution

  • 00732094272338 ()
11094-001-50

  • Patient health record information system application software

Innocor - 05713867000148

Innocor cardio-pulmonary function test equipment
Innovision ApS
INN00300-1
In Commercial Distribution

  • 05713867000148 ()


  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult
  • Cardiopulmonary stress exercise monitoring system

Innocor - 05713867000124

Innocor Cardio-pulmonary function test equipment
Innovision ApS
INN00100-1
In Commercial Distribution

  • 05713867000124 ()


  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult
  • Cardiopulmonary stress exercise monitoring system

Innocor - 05713867000025

Cardio-pulmonary function test & analysis equipment
Innovision ApS
INN00100
In Commercial Distribution

  • 05713867000025 ()


  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult
  • Cardiopulmonary stress exercise monitoring system

Innocor - 05713867000018

Cardio-pulmonary function test & analysis equipment
Innovision ApS
INN00300
In Commercial Distribution

  • 05713867000018 ()


  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult
  • Cardiopulmonary stress exercise monitoring system

Cardio Server - 00860991000386

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
7.1
In Commercial Distribution

  • 00860991000386 ()


  • Cardiology information system application software

Cardio Server - 00860991000362

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
6.2
In Commercial Distribution

  • 00860991000362 ()


  • Cardiology information system application software

Cardio Server - 00860991000393

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
7.4.0
In Commercial Distribution

  • 00860991000393 ()


  • Cardiology information system application software

Cardio Server - 00860991000379

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
7.0
In Commercial Distribution

  • 00860991000379 ()


  • Cardiology information system application software

Cardio Server - 00860991000355

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
6.1
In Commercial Distribution

  • 00860991000355 ()


  • Cardiology information system application software

Epiphany Cardio Server - 00860991000348

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
6.0
In Commercial Distribution

  • 00860991000348 ()


  • Cardiology information system application software

Epiphany Cardio Server - 00860991000331

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
5.4
In Commercial Distribution

  • 00860991000331 ()


  • Cardiology information system application software

Epiphany Cardio Server - 00860991000324

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
5.3
In Commercial Distribution

  • 00860991000324 ()


  • Cardiology information system application software

Epiphany Cardio Server - 00860991000317

ECG Management System is a software only ECG management database that stores, displays, and prints high resolution ECG Data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
5.2.0
In Commercial Distribution

  • 00860991000317 ()


  • Cardiology information system application software

Epiphany Cardio Server - 00860991000300

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
5.1.0
In Commercial Distribution

  • 00860991000300 ()


  • Cardiology information system application software

Xper Information Management System - 00884838070721

No Description
Philips Medical Systems Nederland B.V.
2.1
In Commercial Distribution

  • 00884838070721 ()
453564530681

  • Patient health record information system

Xper Information Management System - 00884838070691

No Description
Philips Medical Systems Nederland B.V.
1.5
In Commercial Distribution

  • 00884838070691 ()
453564495001

  • Patient health record information system

IECG - 00884838032408

No Description
Philips Medical Systems Hsg
B.01.00
In Commercial Distribution

  • 00884838032408 ()


  • Medical equipment clinical data interfacing software

Philips - 00884838030299

No Description
Philips Medical Systems Hsg
860343
In Commercial Distribution

  • 00884838030299 ()
860343

  • Electrocardiograph, professional, multichannel

LumiGuide - 00884838112087

Visualization device with FORS technology intended to aid the positioning and navigation of a connected LumiGuide Wire and optionally a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real time of the connected LumiGuide Wire, and of an endovascular catheter, when combined with a LumiGuide 3D Hub.
Philips Medical Systems Nederland B.V.
LumiGuide Equipment
In Commercial Distribution

  • 00884838112087 ()
NCVC933

  • Diagnostic x-ray digital imaging system workstation application software
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