| Primary Device ID | 10854894005231 |
| NIH Device Record Key | 3725ac82-1d86-4470-86f4-ae918d261e01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QardioBase 2 |
| Version Model Number | B200 |
| Catalog Number | B200-IVB |
| Company DUNS | 080029958 |
| Company Name | QARDIO, 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 | 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 | false |
| OTC Over-The-Counter | false |