Home GUDID 00085003651039 AEYE Health
Primary DI 00085003651039
Brand AEYE Health
Company Aeye Health, Inc.
Model AEYE-DS
Device description 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)
Published 2024-12-12
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name PIB Diabetic Retinopathy Detection Device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PIB Diabetic Retinopathy Detection Device Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00085003651022 Previous GS1 0 00085003651039 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00085003651022 00085003651022 085003651022 0085003651022 00085003651039 00085003651039 085003651039 0085003651039
Regulatory Flags# DUNS number 118503339 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes#