Epicardia 5000

GUDID 00862887000302

Epicardia 5000 is a screening tool for patients who require ambulatory ECG monitoring for extended time periods.

MEDICOMP, INC.

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• Primary Device ID: 00862887000302
• NIH Device Record Key: 609cfadd-28cf-4635-9eb9-8d4d1801d7b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epicardia 5000
• Version Model Number: N/A
• Company DUNS: 057729253
• Company Name: MEDICOMP, INC.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	00862887000302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090834

FDA Product Code

• DSI: Detector And Alarm, Arrhythmia

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: 2023-10-03
• Device Publish Date: 2023-09-25

Devices Manufactured by MEDICOMP, INC.

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• 00862887000302 - Epicardia 5000: 2023-10-03 Epicardia 5000 is a screening tool for patients who require ambulatory ECG monitoring for extended time periods.
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