R-40 1326

GUDID 05060275450387

LIFELINES LIMITED

Electroencephalograph

• Primary Device ID: 05060275450387
• NIH Device Record Key: e62f413d-b97b-4da9-8537-1ef14a19169c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R-40
• Version Model Number: EEG Amplifier
• Catalog Number: 1326
• Company DUNS: 237089235
• Company Name: LIFELINES 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: 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

Customer Support Contacts

• Phone: +441483224245
• Email: wayne.williams@llines.com
• Phone: +441483224245
• Email: wayne.williams@llines.com
• Phone: +441483224245
• Email: wayne.williams@llines.com
• Phone: +441483224245
• Email: wayne.williams@llines.com
• Phone: +441483224245
• Email: wayne.williams@llines.com
• Phone: +441483224245
• Email: wayne.williams@llines.com
• Phone: +441483224245
• Email: wayne.williams@llines.com
• Phone: +441483224245
• Email: wayne.williams@llines.com
• Phone: +441483224245
• Email: wayne.williams@llines.com
• Phone: +441483224245
• Email: wayne.williams@llines.com
• Phone: +441483224245
• Email: wayne.williams@llines.com
• Phone: +441483224245
• Email: wayne.williams@llines.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060275450387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151600

FDA Product Code

• GWL: Amplifier, Physiological Signal

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: 2016-09-16

On-Brand Devices [R-40]

• 05060275450455: EEG Amplifier + BT + WI-FI Kit
• 05060275450448: EEG Amplifier + WI-FI Kit
• 05060275450431: EEG Amplifier + BT Kit
• 05060275450424: EEG Amplifier Kit
• 05060275450417: EEG Amplifier + BT + WI-FI
• 05060275450400: EEG Amplifier + WI-FI
• 05060275450394: EEG Amplifier + BT
• 05060275450387: EEG Amplifier