DEVICE: Virtual Field (00860001720419)

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Device Record History
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Device Identifier (DI) Information
Virtual Field
VF Software
In Commercial Distribution
Release Version 2023.4.2
Field Virtual Inc
00860001720419
GS1

1
099254165 *Terms of Use
Virtual Field is a portable virtual reality visual field device. It runs a variety of visual field patterns, including but not limited to 10-2, 24-2, and 30-2, as well as multiple strategies, from suprathreshold screenings to full threshold tests. It also includes eye tracking capabilities, a color vision screening exam, and a pupillometer exam. The Virtual Field Website is used to launch exams, view patient results, and manage account information.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
13236 Pupillometer, electrically-powered
An electrically-powered ophthalmic instrument intended to be used for measuring the width or diameter of the pupil. The patient will, e.g., view into this device and the operator will see the pupil and its shape.
Active false
16918 Perimeter, automatic
A mains electricity (AC-powered), automatically operated, diagnostic, ophthalmic instrument intended for assessing the extent of the patient's peripheral visual field. Small luminous points (spots) are automatically displayed in various random positions and patient response is automatically recorded. The print-out (chart) then shows the resulting curve of the visual field. Such types include Humphrey perimeters.
Active false
32687 Colour discrimination tester
An ophthalmic device that consists of various coloured materials, e.g., coloured yarns or colour vision plates (multicoloured plates which patients with colour vision deficiency would perceive as being of one colour), used for evaluating colour vision.
Active false
13235 Pupillograph
A mains electricity (AC-powered) graphic recorder used for recording the response of the pupil to reflected light. It is used for ophthalmic diagnostic purposes.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HPT Perimeter, Automatic, Ac-Powered
HRI Pupillograph
HIT Tester, Color Vision
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
a6b5a847-5ea6-47d0-8b7b-f1b7c85c6c8d
May 23, 2023
6
January 23, 2023
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
(858) 208-0074
support@virtualfield.io
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