neon12

GUDID 05391530950022

EEG electrode array sized for use with neonatal infants. The array has qty 12 electrodes. The device is single use only

INCEREB LIMITED

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• Primary Device ID: 05391530950022
• NIH Device Record Key: b35b0830-3759-4a30-9585-c033f00a7fc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: neon12
• Version Model Number: TF01
• 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

Customer Support Contacts

• Phone: +35316852245
• Email: pphillips@incereb.com
• Phone: +35316852245
• Email: pphillips@incereb.com
• Phone: +35316852245
• Email: pphillips@incereb.com
• Phone: +35316852245
• Email: pphillips@incereb.com
• Phone: +35316852245
• Email: pphillips@incereb.com
• Phone: +35316852245
• Email: pphillips@incereb.com
• Phone: +35316852245
• Email: pphillips@incereb.com
• Phone: +35316852245
• Email: pphillips@incereb.com
• Phone: +35316852245
• Email: pphillips@incereb.com
• Phone: +35316852245
• Email: pphillips@incereb.com
• Phone: +35316852245
• Email: pphillips@incereb.com
• Phone: +35316852245
• Email: pphillips@incereb.com
• Phone: +35316852245
• Email: pphillips@incereb.com
• Phone: +35316852245
• Email: pphillips@incereb.com
• Phone: +35316852245
• Email: pphillips@incereb.com
• Phone: +35316852245
• Email: pphillips@incereb.com
• Phone: +35316852245
• Email: pphillips@incereb.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391530950008 [Primary]
GS1	05391530950015 [Package]; Contains: 05391530950008; Package: box [5 Units]; In Commercial Distribution
GS1	05391530950022 [Package]; Contains: 05391530950015; Package: box [4 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

Devices Manufactured by INCEREB LIMITED

• 05391530950091 - Neon 12 KIT: 2022-04-01 Kit version of neon12, packaged without electrode paste or skin prep gel
• 05391530950121 - Neon8 KIT: 2022-04-01 Neon8 KIT version, packaged without electrode paste or skin prep gel
• 05391530950084 - neon8: 2022-01-24 EEG electrode array sized for use with neonatal infants. The array has qty 8 electrodes. The device is single use only. This
• 05391530950022 - neon12: 2018-07-06EEG electrode array sized for use with neonatal infants. The array has qty 12 electrodes. The device is single use only
• 05391530950022 - neon12: 2018-07-06 EEG electrode array sized for use with neonatal infants. The array has qty 12 electrodes. The device is single use only
• 05391530950053 - neon8: 2018-07-06 EEG electrode array sized for use with neonatal infants. The array has qty 8 electrodes. The device is single use only