AccessGUDID - DEVICE: myVisionTrack (00860003376157)

GUDID

Device Identifier (DI) Information

Brand Name: myVisionTrack
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Brightinsight, Inc.

Primary DI Number: 00860003376157
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080811955 *Terms of Use

Device Description: Vision testing application - iOS version

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QTW	Digital Amsler Grid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8f8fa246-d92e-43fc-b22a-62821dd3db27
Public Version Date: February 11, 2025
Public Version Number: 2
DI Record Publish Date: January 09, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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