Cardio Server

GUDID 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

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• Primary Device ID: 00860991000386
• NIH Device Record Key: 032c0737-cd71-4b95-b3f2-88ae6f9f29eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardio Server
• Version Model Number: 7.1
• 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	00860991000386 [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: 2023-08-08
• Device Publish Date: 2023-07-31

On-Brand Devices [Cardio Server ]

• 00860991000362: ECG Management System is a software only EGG management database that stores, displays, and prin
• 00860991000379: ECG Management System is a software only EGG management database that stores, displays, and prin
• 00860991000386: ECG Management System is a software only EGG management database that stores, displays, and pr
• 00860991000393: ECG Management System is a software only EGG management database that stores, displays, and prin