Vestibular First

Primary DI
00860002280707
Brand
Vestibular First
Company
Vestibular First, LLC
Model
Insight Infrared Video Goggles
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.
Published
2020-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWNNystagmograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWNNystagmographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203082000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203082000Insight Infrared Video GogglesVestibular First2020-11-12GWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860002280704PackageGS16In Commercial Distribution
00860002280707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000228070410860002280704
00860002280707008600022807078600022807070860002280707

GMDN Terms#

Term, Definition table
TermDefinition
Vision/eye movement analysis systemAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Storage Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
2156678990support@vestibularfirst.com

Regulatory Flags#

DUNS number
016038297
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860002280738Vestibular FirstInsight Infrared Video Goggles ProINSIGHT-VIDEO-GOGGLES-PRO2021-11-11
00860002280745Vestibular FirstInsight Infrared Video Goggles Pro+INSIGHT-PRO-PLUS2023-06-01
00860002280714Vestibular FirstInsight Disposable Cushions - 40-CountPART-DISPOSABLE-CUSHION-40CT2023-06-01
10860002280742Vestibular FirstInsight Infrared Video Goggles Pro+INSIGHT-PRO-PLUS2023-06-01
10860002280735Vestibular FirstInsight Infrared Video Goggles ProINSIGHT-VIDEO-GOGGLES-PRO2021-11-11

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00860013612900EYE-SYNCNEUROSYNC INC.GWN2025-03-12
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