AEYE Health

GUDID 00850035651018

AEYE-DS-Epic is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS-Epic is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR) and is integrated with the Epic EMR.

Aeye Health, Inc.

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• Primary Device ID: 00850035651018
• NIH Device Record Key: a0d14539-96fe-4144-804d-b14ff231370d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AEYE Health
• Version Model Number: AEYE-DS-Epic
• Company DUNS: 118503339
• Company Name: Aeye Health, 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850035651018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221183

FDA Product Code

• PIB: Diabetic Retinopathy Detection Device

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-24
• Device Publish Date: 2023-07-16

On-Brand Devices [AEYE Health]

• 00850035651018: AEYE-DS-Epic is a retinal diagnostic software device that incorporates an algorithm to evaluate
• 00850035651001: AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophth
• 00085003651022: AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophth