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
Insight Infrared Video Goggles Pro
In Commercial Distribution
INSIGHT-VIDEO-GOGGLES-PRO
Vestibular First, LLC
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GWN | Nystagmograph |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K203082 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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 |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c7a4f58e-2113-453e-9a9f-6574b2f67218
November 19, 2021
1
November 11, 2021
November 19, 2021
1
November 11, 2021
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
215-667-8990
support@vestibularfirst.com
support@vestibularfirst.com