neon8

GUDID 05391530950084

EEG electrode array sized for use with neonatal infants. The array has qty 8 electrodes. The device is single use only. This new DI is a new packaging format. The old number was a tray with a peel off lid. This DI is the "Clamshell" in a pouch packaging

INCEREB LIMITED

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• Primary Device ID: 05391530950084
• NIH Device Record Key: 80df5894-6387-475d-ab75-76b425f8aee7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: neon8
• Version Model Number: TF04
• Company DUNS: 985065024
• Company Name: INCEREB LIMITED
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391530950039 [Previous]
GS1	05391530950077 [Primary]
GS1	05391530950084 [Package]; Contains: 05391530950077; Package: box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151576

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: 2022-01-24
• Device Publish Date: 2022-01-16

On-Brand Devices [neon8]

• 05391530950053: EEG electrode array sized for use with neonatal infants. The array has qty 8 electrodes. The d
• 05391530950084: EEG electrode array sized for use with neonatal infants. The array has qty 8 electrodes. The d