AccessGUDID - DEVICE: Home Vision Monitor® (00860004152705)

GUDID

Device Identifier (DI) Information

Brand Name: Home Vision Monitor®
Version or Model: Model 0005
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: VITAL ART AND SCIENCE, LLC

Primary DI Number: 00860004152705
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 782794213 *Terms of Use

Device Description: The Home Vision Monitor® Model 0005 is a vision function test provided as a downloadable app on to the user’s supplied cell phone or tablet. The Home Vision Monitor® Model 0005 implements a shape discrimination hyperacuity (SDH) vision test which allows patients to perform their own vision test at home. If a significant worsening of vision function is detected the physician will be notified and provided access to the vision self-test results so that they can decide whether the patient needs to be seen sooner than their next already scheduled appointment.

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?
16800	Vision testing/training chart	An ophthalmic chart or card printed with various symbols (e.g., letters, pictures or dots) intended to be used for testing visual acuity (e.g., Snellen chart) or testing and/or training accommodation and/or convergence or other amenable ophthalmic functions. The chart/card may be held in front of the patient or placed on a table or wall and may have specific user instructions depending on specific use. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HOQ	Grid, Amsler

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143211	000

Device Exempt from Premarket Submission: No 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: e2b05443-1510-4125-b223-2adaf42676d8
Public Version Date: March 07, 2022
Public Version Number: 2
DI Record Publish Date: August 17, 2020