REMI

GUDID 08600053881650

REMI Tablet

Epitel, Inc.

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• Primary Device ID: 08600053881650
• NIH Device Record Key: fe7dd9bc-670a-428c-a0b2-cd18eccc821f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REMI
• Version Model Number: R001
• Company DUNS: 808401157
• Company Name: Epitel, 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08600053881650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203827

FDA Product Code

• OMC: Reduced- Montage Standard Electroencephalograph

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: 2022-01-10
• Device Publish Date: 2022-01-01

On-Brand Devices [REMI]

• 08600053881650: REMI Tablet
• 00860011072430: REMI Daily Sticker Kit
• 00860011072423: REMI Sticker
• 00860005388172: REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Use Module
• 00860005388165: REMI Wireless EEG Sensor