Vestibular First

Basic Information

• Brand Name: Vestibular First
• Primary DI: 00860002280707
• Version / Model: Insight Infrared Video Goggles
• Company Name: Vestibular First, LLC
• Labeler DUNS: 016038297
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-17
• Public Version: 1
• Public Version Date: 2020-11-25
• Public Version Status: New
• Public Device Record Key: d833038b-1e92-4942-b21d-67cc61c7fc23

Device Description

The Insight Infrared Video Goggles are designed to be used by clinicians to visualize and record patient eye movements. The goggles will be placed on the patient’s head with the cameras in front of the patient’s eyes. The infrared cameras transmit video of the eye movements to a compatible computer screen for display. The computer uses an off-the-shelf video software Open Broadcaster Software (OBS) to allow viewing and recording of the cameras.

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: Yes
• 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
GWN	Nystagmograph	Neurology	882.1460	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46390	Vision/eye movement analysis system	An electronic unit or device assembly intended to measure, record, and display a range of parameters associated with vision electrophysiology [e.g., electroretinogram (ERG), visual evoked potential (VEP), electrooculogram (EOG)], and/or psychophysical vision (e.g., visual acuity/fields, refractive error, contrast sensitivity, colour perception), and/or eye movement (e.g., pupillary response, saccades, pursuits, fixations) for vision evaluation/screening. Features may include visual stimuli (e.g., patterns of light/images) and/or devices for sensing/tracking (e.g., bioelectric amplifiers, video or infrared cameras). It is intended to be used by a healthcare professional in a clinical setting.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10860002280704	GS1	Box	6	In Commercial Distribution
Primary	00860002280707	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K203082	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 80 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 30 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 80 – 106 KiloPascal