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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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SWAN-GANZ - 00690103217704

Patient CCO cable - HemoSphere Alta advanced monitoring platform
Edwards Lifesciences LLC
HEMA70CC2
In Commercial Distribution

  • 00690103217704 ()

  • Length: 8.0000 Feet
HEMA70CC2

  • Electrical-only medical device connection cable, reusable

HEMOSPHERE - 00690103216998

Mindray OEM Pressure Smart Cable
Edwards Lifesciences LLC
PSCOEM100MR
In Commercial Distribution

  • 00690103216998 ()
PSCOEM100MR

  • General-purpose multi-parameter bedside monitor

ECGenius System - 05745001034009

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 R3.2
In Commercial Distribution

  • 05745001034009 ()
CVT-0069 R3.2 ECGenius System

  • Cardiac electrophysiology analysis system

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 - 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 - 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 - 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 - 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
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