R-40 (24) 1413

GUDID 05060275450738

LIFELINES LIMITED

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• Primary Device ID: 05060275450738
• NIH Device Record Key: 47783f23-0d3f-419c-86a3-71687bc140a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R-40 (24)
• Version Model Number: Amp + WI-FI
• Catalog Number: 1413
• 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@lifelinesneuro.com
• Phone: +441483224245
• Email: wayne.williams@lifelinesneuro.com
• Phone: +441483224245
• Email: wayne.williams@lifelinesneuro.com
• Phone: +441483224245
• Email: wayne.williams@lifelinesneuro.com
• Phone: +441483224245
• Email: wayne.williams@lifelinesneuro.com
• Phone: +441483224245
• Email: wayne.williams@lifelinesneuro.com
• Phone: +441483224245
• Email: wayne.williams@lifelinesneuro.com
• Phone: +441483224245
• Email: wayne.williams@lifelinesneuro.com
• Phone: +441483224245
• Email: wayne.williams@lifelinesneuro.com
• Phone: +441483224245
• Email: wayne.williams@lifelinesneuro.com
• Phone: +441483224245
• Email: wayne.williams@lifelinesneuro.com
• Phone: +441483224245
• Email: wayne.williams@lifelinesneuro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060275450738 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-04
• Device Publish Date: 2020-01-27

On-Brand Devices [R-40 (24)]

• 05060275450783: Amp + BT + WI-FI Kit
• 05060275450776: Amp + WI-FI Kit
• 05060275450769: Amp + BT Kit
• 05060275450752: Amp Kit
• 05060275450745: Amp + BT + WI-FI
• 05060275450738: Amp + WI-FI
• 05060275450721: Amp + BT
• 05060275450714: Amp