| Primary Device ID | 00088291600001 |
| NIH Device Record Key | a29f9bd2-c01c-4769-8fa5-8c47ab409022 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | cvi42 |
| Version Model Number | 5.6 |
| Company DUNS | 248028578 |
| Company Name | Circle Cardiovascular Imaging Inc |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |