| Primary Device ID | 00697077003043 |
| NIH Device Record Key | 58ef1047-aff1-4f0f-a796-0a8bff4cd3a4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DS-UDN-CLFL-DAI |
| Version Model Number | DS-UDN-CLFL-DAI |
| 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 | true |
| 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 | 00697077003043 [Primary] |
| HLI | Ophthalmoscope, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-02-28 |
| Device Publish Date | 2024-07-11 |
| 00697077003043 - DS-UDN-CLFL-DAI | 2025-02-28Diag. Station -Oph & Oto LED, Spec Disp, Aneroid & Chld Cuf,IR Therm,Dino Board Child 2-Piece Cuff, 2 Tube LF, Green, Infl Bulb x Screw Female (DI 00697077000561) Diagnostic Station Wall Mount, Ophthal & Oto LED (DI 00697077001353) Genius 3 Tympanic Thermometer and Base (DI 10884521738522) |
| 00697077003043 - DS-UDN-CLFL-DAI | 2025-02-28 Diag. Station -Oph & Oto LED, Spec Disp, Aneroid & Chld Cuf,IR Therm,Dino Board Child 2-Piece Cuff, 2 Tube LF, Green, Infl Bulb |
| 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 |