| Primary Device ID | 04719876420053 |
| NIH Device Record Key | 4a12bbfa-88b9-49db-8acc-1fe5ce1992b3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NFC-700 |
| Version Model Number | NFC-700 |
| Catalog Number | 700-C1101-031 |
| Company DUNS | 658841648 |
| Company Name | CRYSTALVUE MEDICAL CORPORATION |
| 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 | true |
| 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 |
| Phone | +88633607711 |
| Oliver.Lin@crystalvue.com.tw |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719876420053 [Primary] |
| HKI | Camera, Ophthalmic, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-07-02 |
| Device Publish Date | 2019-03-04 |
| 04719876420398 - Vitazi View™ | 2024-05-28 Automated Portable Retinal Camera |
| 04719876420268 - NFC-600 | 2021-07-19 Automated Portable Retinal Camera |
| 04719876420275 - Halo | 2021-07-19 Automated Portable Retinal Camera |
| 04719876420176 - Polaris | 2020-07-28 Non-Mydriatic Auto Fundus Camera |
| 04719876420060 - RetinaStation | 2020-07-02 Non-Mydriatic Auto Fundus Camera |
| 04719876420053 - NFC-700 | 2020-07-02Non-Mydriatic Auto Fundus Camera |
| 04719876420053 - NFC-700 | 2020-07-02 Non-Mydriatic Auto Fundus Camera |