| Primary Device ID | B334DBX1P40 |
| NIH Device Record Key | 806f2db0-7e37-4663-be92-4c9734dd00f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DBx |
| Version Model Number | 1.4 |
| Company DUNS | 211100325 |
| Company Name | MIRADA MEDICAL LIMITED |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B334DBX1P40 [Primary] |
| OUG | Medical Device Data System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-16 |
| Device Publish Date | 2020-10-08 |
| B334RTX1P100 - RTx | 2024-11-06 |
| B334SY2P120 - Simplicit90Y | 2024-03-05 |
| B334XD4P20 - XD | 2024-02-15 |
| B334SY2P10 - Simplicit90Y | 2023-08-31 |
| B334XD4P00 - XD | 2022-05-13 |
| B334SY2P60 - Simplicit90Y | 2021-09-03 |
| B334WORKFLOWBOX2P60 - Workflow Box | 2021-05-12 |
| B334WORKFLOWBOX2P40 - Workflow Box | 2021-04-09 |