EpiMonitor

GUDID 00853858006386

EMPATICA SRL

Home seizure monitoring system

• Primary Device ID: 00853858006386
• NIH Device Record Key: 11706d13-b1a9-4393-9467-c98dfc5d3d70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EpiMonitor
• Version Model Number: EpiMonitor App Android
• Company DUNS: 430141750
• Company Name: EMPATICA SRL
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853858006386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232915

FDA Product Code

• POS: Physiological Signal Based Seizure Monitoring System

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: 2024-08-22
• Device Publish Date: 2024-08-14

On-Brand Devices [EpiMonitor]

• 00853858006386: EpiMonitor App Android
• 00853858006379: EpiMonitor App iOS