Epiphany Cardio Server

GUDID 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

Cardiology information system application software
Primary Device ID00860991000317
NIH Device Record Key1cb03405-94b6-48e3-b161-9d5be8e2c2ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameEpiphany Cardio Server
Version Model Number5.2.0
Company DUNS079747524
Company NameEPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860991000317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQKComputer, Diagnostic, Programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-17

On-Brand Devices [Epiphany Cardio Server ]

00860991000324ECG Management System is a software only EGG management database that stores, displays, and prin
00860991000317ECG Management System is a software only ECG management database that stores, displays, and prin
00860991000300ECG Management System is a software only EGG management database that stores, displays, and prin
00860991000348ECG Management System is a software only EGG management database that stores, displays, and prin

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