Vestibular First

Basic Information

• Brand Name: Vestibular First
• Primary DI: 00860002280714
• Version / Model: Insight Disposable Cushions - 40-Count
• Catalog Number: PART-DISPOSABLE-CUSHION-40CT
• Company Name: Vestibular First, LLC
• Labeler DUNS: 016038297
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-01
• Public Version: 1
• Public Version Date: 2023-06-09
• Public Version Status: New
• Public Device Record Key: 656bc10b-3dcd-48ee-a9b2-57ead46d1fe6

Device Description

The disposable cushion for the Insight series of Video Goggles are designed for settings where infection control is top priority. The cushions are easy to replace with simple hook and loop connection, comfortable for patients, and have excellent light-blocking properties. Cushions are one-time use and are not reusable. This box contains 40 cushions.

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• 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
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860002280714	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 Atmospheric Pressure
• Temperature Range: 80 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius