| Primary Device ID | 00697077002558 |
| NIH Device Record Key | 21d8bb6a-56a6-4401-822b-1dd84c64dd5f |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | DS-KR1-CHFH-DAX |
| Company DUNS | 203163290 |
| Company Name | Amico Diagnostic Incorporated |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00697077002558 [Primary] |
| HLI | Ophthalmoscope, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-08 |
| Device Publish Date | 2020-04-30 |
| 00697077003050 - Amico Diagnostic, Inc. | 2024-09-26 Diagnostic Station Ophthalmoscope & Otoscope LED, Spec Dispenser, Aneroid & Adult Cuff, Thermometer, Grey Wallboard Ophthalmosco |
| 00697077003036 - NA | 2024-07-02 |
| 00697077003029 - NA | 2024-05-10 |
| 00697077002237 - NA | 2023-08-04 |
| 00697077002985 - NA | 2023-08-04 |
| 00697077002992 - NA | 2023-08-04 |
| 00697077003005 - NA | 2023-08-04 |
| 00697077003012 - NA | 2023-08-04 |