Trackit T4

GUDID 05060275450509

LIFELINES LIMITED

Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder

• Primary Device ID: 05060275450509
• NIH Device Record Key: 7a121c49-418e-49a1-85e7-ccbf5fd80bd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trackit T4
• Version Model Number: T4-32
• 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	05060275450509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151600

FDA Product Code

• GWQ: Full-Montage Standard Electroencephalograph

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: 2018-02-19

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