Home GUDID B300A00050 EpiAccess Control Unit
Primary DI B300A00050
Brand EpiAccess Control Unit
Company EPIEP, INC.
Model A0005
Published 2017-09-18
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name DYB Introducer, Catheter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DYB Introducer, Catheter Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B300A00050 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Cardiac catheterization monitoring system An assembly of devices designed to continuously obtain, amplify, and record various signals generated during procedures usually performed in the cardiac catheterization laboratory. It typically consists of a computerized central workstation including a monitor and a graphic recorder, and a slave monitor including patient interface modules in the catheterization laboratory. The system is used for procedures such as left heart catheterization, right heart catheterization ventriculograms, coronary angiography, and pacemaker insertions; also used in procedures intended for the determination of most haemodynamic characteristics, evaluation of therapies, and planning of surgical approaches.
Regulatory Flags# DUNS number 965279909 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B3000399139500 EpiAccess Needle 0399-13950 2016-09-23 B300A00020 EpiAccess Control Unit A0002 2016-09-23
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