DEVICE: Vestibular First (00860002280738)

Device Identifier (DI) Information

Vestibular First
Insight Infrared Video Goggles Pro
In Commercial Distribution
INSIGHT-VIDEO-GOGGLES-PRO
Vestibular First, LLC
00860002280738
GS1

1
016038297 *Terms of Use
The Insight Infrared Video Goggles Pro are intended for viewing and recording eye movements in support of identifying vestibular disorders in patients. The device is intended for use only by a trained healthcare professional in an appropriate healthcare setting. This device provides no diagnoses nor does it provide diagnostic recommendations. The target population is 12+ years of age.
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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?
64414 Eye/eyelid movement monitoring spectacles/goggles
An electrically-powered optical device intended to monitor eyelid and/or eye movements to assist in the detection of alertness/drowsiness, epileptic seizures, and/or to assist in the identification of vestibular disorder. It consists of a spectacle/goggle-like frame and may include an infrared sensor(s), infrared LED(s), infrared video camera(s), and/or a photodiode(s); it transmits a digital signal to a processing unit, which may use an off-the-shelf video viewing software application.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GWN Nystagmograph
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K203082 000
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Sterilization

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

[?]
Storage and Handling
Handling Environment Atmospheric Pressure: between 80 and 106 KiloPascal
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 50 Degrees Celsius
Storage Environment Atmospheric Pressure: between 80 and 106 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 50 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

c7a4f58e-2113-453e-9a9f-6574b2f67218
November 19, 2021
1
November 11, 2021
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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
10860002280735 6 00860002280738 In Commercial Distribution Box
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Secondary DI

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

[?]
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
Yes
No
Yes
No CLOSE

Customer Contact

[?]
215-667-8990
support@vestibularfirst.com
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