AEYE Health

GUDID 00085003651022

AEYE-DS 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 is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR)

Aeye Health, Inc.

Retinal image analysis software Retinal image analysis software Retinal image analysis software Retinal image analysis software Retinal image analysis software Retinal image analysis software Retinal image analysis software Retinal image analysis software Retinal image analysis software Retinal image analysis software Retinal image analysis software Retinal image analysis software Retinal image analysis software Retinal image analysis software Retinal image analysis software

• Primary Device ID: 00085003651022
• NIH Device Record Key: 2cd00afd-2163-4398-9b21-7427ad64ccad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AEYE Health
• Version Model Number: AEYE-DS
• 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: true
• 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

Customer Support Contacts

• Phone: 1 866 262 7343
• Email: support@aeyehealth.com
• Phone: 1 866 262 7343
• Email: support@aeyehealth.com
• Phone: 1 866 262 7343
• Email: support@aeyehealth.com
• Phone: 1 866 262 7343
• Email: support@aeyehealth.com
• Phone: 1 866 262 7343
• Email: support@aeyehealth.com
• Phone: 1 866 262 7343
• Email: support@aeyehealth.com
• Phone: 1 866 262 7343
• Email: support@aeyehealth.com
• Phone: 1 866 262 7343
• Email: support@aeyehealth.com
• Phone: 1 866 262 7343
• Email: support@aeyehealth.com
• Phone: 1 866 262 7343
• Email: support@aeyehealth.com
• Phone: 1 866 262 7343
• Email: support@aeyehealth.com
• Phone: 1 866 262 7343
• Email: support@aeyehealth.com
• Phone: 1 866 262 7343
• Email: support@aeyehealth.com
• Phone: 1 866 262 7343
• Email: support@aeyehealth.com
• Phone: 1 866 262 7343
• Email: support@aeyehealth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085003651022 [Primary]
GS1	00850035651001 [Previous]

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: 2023-10-06
• Device Publish Date: 2023-09-28

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