myVisionTrack

Basic Information

• Brand Name: myVisionTrack
• Primary DI: 00860003376102
• Version / Model: 1.1
• Company Name: Brightinsight, Inc.
• Labeler DUNS: 080811955
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-09
• Public Version: 1
• Public Version Date: 2024-01-17
• Public Version Status: New
• Public Device Record Key: b0a20439-29f2-46af-83f4-2819518f49f9

Device Description

Vision testing application - android version

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: Yes
• Has Serial Number: No
• 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
QTW	Digital Amsler Grid	Ophthalmic	886.1330	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65889	Vision self-testing software	A software as a medical device (SaMD) application intended to be used by a patient for self-testing of visual function under consultation of a clinician (e.g., ophthalmologist). It provides on-screen images (e.g., shapes) whereby visual function can be tested over time (e.g., to monitor macular degeneration). It is intended to store and allow communication of the results with healthcare professionals.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860003376102	GS1