Trackit 1187

GUDID 05060275450004

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: 05060275450004
• NIH Device Record Key: 9c69eb89-3faa-4abd-86e2-db853d32f132
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trackit
• Version Model Number: Trackit 3 BT 24/0
• Catalog Number: 1187
• 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	05060275450004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010460

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: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-09

On-Brand Devices [Trackit]

• 05060275450325: Trackit 20/4/B Kit
• 05060275450318: Trackit 20/4 Kit
• 05060275450301: Trackit 18/8/B Kit
• 05060275450295: Trackit 18/8 Kit
• 05060275450288: Trackit 32/0/B Kit
• 05060275450271: Trackit 32/0 Kit
• 05060275450264: Trackit 24/0/B Kit
• 05060275450257: Trackit 24/0 Kit
• 05060275450240: Trackit 12/0/B Kit
• 05060275450233: Trackit 12/0 Kit
• 05060275450226: Trackit 24/8/B Kit
• 05060275450219: Trackit 24/8 Kit
• 05060275450202: Trackit 3 BT 12/0/B
• 05060275450196: Trackit 3 BT 24/8/B
• 05060275450189: Trackit 3 BT 12/0
• 05060275450172: Trackit 3 BT 24/8
• 05060275450073: Trackit 3 BT 32/0/B
• 05060275450066: Trackit 3 BT 18/8/B
• 05060275450059: Trackit 3 BT 20/4/B
• 05060275450042: Trackit 3 BT 24/0/B
• 05060275450035: Trackit 3 BT 32/0
• 05060275450028: Trackit 3 BT 18/8
• 05060275450011: Trackit 3 BT 20/4
• 05060275450004: Trackit 3 BT 24/0