Trackit T4

GUDID 05060275450561

LIFELINES LIMITED

Electroencephalographic ambulatory recorder

• Primary Device ID: 05060275450561
• NIH Device Record Key: 83182769-0726-4114-9b5c-ed8d91f95689
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trackit T4
• Version Model Number: T4-68 + WI-FI Kit
• 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	05060275450561 [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: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-02-23

On-Brand Devices [Trackit T4]

• 05060275450615: T4-32 + BT + WI-FI Kit
• 05060275450608: T4-32 + WI-FI Kit
• 05060275450592: T4-32 + BT Kit
• 05060275450585: T4-32 Kit
• 05060275450578: T4-68 + BT + WI-FI Kit
• 05060275450561: T4-68 + WI-FI Kit
• 05060275450554: T4-68 + BT Kit
• 05060275450547: T4-68 Kit
• 05060275450530: T4-32 + BT + WI-FI
• 05060275450523: T4-32 + WI-FI
• 05060275450516: T4-32 + BT
• 05060275450509: T4-32
• 05060275450493: T4-68 + BT + WI-FI
• 05060275450486: T4-68 + WI-FI
• 05060275450479: T4-68 + BT
• 05060275450462: T4-68