Trackit T4

Basic Information

• Brand Name: Trackit T4
• Primary DI: 05060275450547
• Version / Model: T4-68 Kit
• Company Name: LIFELINES LIMITED
• Labeler DUNS: 237089235
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-23
• Public Version: 6
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 83332f5f-3a6d-4d4b-b6ce-609c82b08104

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWL	Amplifier, Physiological Signal	Neurology	882.1835	2
GWQ	Full-Montage Standard Electroencephalograph	Neurology	882.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35163	Electroencephalographic ambulatory recorder	A portable electrically-powered device designed for recording of electroencephalographic signals in ambulatory patients for periods usually from 24 to 72 hours to assess a variety of neurological conditions (e.g., epilepsy) and psychiatric disorders; it is not intended for inpatient monitoring. It is a small unit designed to be worn by the patient with an appropriate signal amplifier, and intended to be used with a set of scalp electrodes that are placed on the cranium of the patient. The resulting electroencephalogram (EEG) data is analysed after the recording period using an appropriate computer/software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060275450547	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K151600	000
K172271	000