| Primary Device ID | B475PVUETSC101 |
| NIH Device Record Key | 55f362ae-e150-4700-a825-af7c9b2ffd44 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Photonvue box |
| Version Model Number | PVUE-TSC-1.0 |
| Company DUNS | 260631677 |
| Company Name | FLUOPTICS |
| 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 | true |
| 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 |
|---|---|
| HIBCC | B475PVUETSC101 [Primary] |
| OWN | Confocal Optical Imaging |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-01-19 |
| B475FMSA0 - FLUOPOD | 2023-10-09 |
| B475FKCL0 - FLUOCART | 2022-02-08 |
| B475FBLM0 - FLUOBEAM LM | 2021-02-26 Fluorescence imaging system |
| B475LXHO0 - FLUOCLIP | 2021-02-26 |
| B475FBLX0 - FLUOBEAM LX | 2019-09-13 Fluorescence imaging system |
| B475FB800CLV190 - FLUOBEAM 800 | 2018-07-26 |
| B475FC800CLV190 - FLUOCASE 800 | 2018-07-26 |
| B475FB800CLV180 - FLUOBEAM 800 | 2018-07-06 |