| Primary Device ID | 00085003651039 |
| NIH Device Record Key | 21fe7e88-d04d-4d08-90a0-340f0e2c3558 |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00085003651022 [Previous] |
| GS1 | 00085003651039 [Primary] |
| PIB | Diabetic Retinopathy Detection Device |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-20 |
| Device Publish Date | 2024-12-12 |
| 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 |
| 00085003651039 | AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophth |