| Primary Device ID | 04712558769037 |
| NIH Device Record Key | 02378a9c-db16-4027-a1da-ddab74d94400 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | eB-series |
| Version Model Number | eB-series |
| Company DUNS | 656031619 |
| Company Name | VISGENEER, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04712558769037 [Primary] |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-13 |
| Device Publish Date | 2023-07-05 |
| 04712558761116 - eBuricacid | 2023-07-13 blood uric acid monitoring system contains meter 1pcs, test strip 25pcs, lancing device 1pcs and lancet 25pcs |
| 04712558761123 - eBuricacid | 2023-07-13 blood uric acid test strip 25pcs |
| 04712558761277 - LANCET | 2023-07-13 100pcs |
| 04712558769037 - eB-series | 2023-07-13blood uric acid control solution: one vial |
| 04712558769037 - eB-series | 2023-07-13 blood uric acid control solution: one vial |
| 04712558769402 - eBchek | 2023-07-13 blood glucose monitoring system contains meter, test strips, lancing device and lancets |
| 04712558769419 - eBchek | 2023-07-13 blood glucose test strips 50pcs |
| 14712558769409 - eBchek | 2021-04-02 |
| 14712558769416 - eBchek | 2021-04-02 |