Ceribell EEG Headcap, Medium

GUDID 00851420007083

CERIBELL, INC.

Analytical scalp electrode, single-use

• Primary Device ID: 00851420007083
• NIH Device Record Key: ff10930a-be2d-4573-baf3-d7bbbb029fb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceribell EEG Headcap, Medium
• Version Model Number: C252
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851420007083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223086

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2024-03-18
• Device Publish Date: 2024-03-08

Devices Manufactured by CERIBELL, INC.

• 00851420007076 - Ceribell EEG Headcap, Small: 2024-03-18
• 00851420007083 - Ceribell EEG Headcap, Medium: 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