Pocket EEG Device

GUDID 00851420007052

CERIBELL, INC.

Electroencephalograph

• Primary Device ID: 00851420007052
• NIH Device Record Key: a856b3a9-e493-4973-8a57-6fb6ecbb4d30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pocket EEG Device
• Version Model Number: C100
• Company DUNS: 079897397
• Company Name: CERIBELL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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	00851420007007 [Previous]
GS1	00851420007052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170363

FDA Product Code

• OMB: Automatic Event Detection Software For Full-Montage 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: 2021-08-10
• Device Publish Date: 2021-08-02

On-Brand Devices [Pocket EEG Device]

• 00851420007007: C100
• 00851420007052: C100