iScreen Vision

GUDID 00864218000104

The iScreen Vision Screener 3000 is a vision screening tool intended to capture and record red reflex images which contain information on ocular status to aid in eye examination. The iScreen Vision Screener 3000 is intended for use solely for a pediatric population by trained professionals.

ISCREEN VISION, INC.

External ocular measurement camera

• Primary Device ID: 00864218000104
• NIH Device Record Key: 578c673b-8a53-4f09-9f11-06f794ee6dbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iScreen Vision
• Version Model Number: iScreen Vision Screener 3000
• Company DUNS: 035304046
• Company Name: ISCREEN VISION, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 901-201-6132
• Email: info@iscreenvision.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864218000104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102651

FDA Product Code

• HKI: Camera, Ophthalmic, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23