Cardio Server

GUDID 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

Cardiology information system application software

• Primary Device ID: 00860991000355
• NIH Device Record Key: 783553e1-3150-4d57-85d8-9fa81e559dac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardio Server
• Version Model Number: 6.1
• Company DUNS: 079747524
• Company Name: EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860991000355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052883

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-27
• Device Publish Date: 2021-07-19

Devices Manufactured by EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC

• 00860991000393 - Cardio Server: 2024-03-20 ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
• 00860991000386 - Cardio Server: 2023-08-08 ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
• 00860991000379 - Cardio Server: 2022-11-08 ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
• 00860991000362 - Cardio Server: 2022-03-03 ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
• 00860991000355 - Cardio Server: 2021-07-27ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
• 00860991000355 - Cardio Server: 2021-07-27 ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
• 00860991000348 - Epiphany Cardio Server: 2020-12-30 ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
• 00860991000300 - Epiphany Cardio Server: 2019-02-28 ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
• 00860991000324 - Epiphany Cardio Server: 2018-12-13 ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data