Pocket EEG Device, EEG Recording Viewer Software

GUDID 00851420007045

CERIBELL, INC.

Electroencephalograph

• Primary Device ID: 00851420007045
• NIH Device Record Key: 60ffd57a-543f-42db-ad42-ff14ed294fc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pocket EEG Device, EEG Recording Viewer Software
• Version Model Number: SW-00001
• Company DUNS: 079897397
• Company Name: CERIBELL, 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	00851420007045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170363

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-28

Devices Manufactured by CERIBELL, INC.

• 00851420007076 - Ceribell EEG Headcap, Small: 2024-03-18
• 00851420007083 - Ceribell EEG Headcap, Medium: 2024-03-18
• 00851420007052 - Pocket EEG Device: 2021-08-10
• 00851420007007 - Pocket EEG Device: 2018-07-06
• 00851420007021 - Ceribell EEG Headband, small size: 2018-07-06
• 00851420007038 - Ceribell EEG Headband, medium size: 2018-07-06
• 00851420007045 - Pocket EEG Device, EEG Recording Viewer Software: 2018-07-06
• 00851420007045 - Pocket EEG Device, EEG Recording Viewer Software: 2018-07-06