| Primary Device ID | 08717953256645 |
| NIH Device Record Key | 9b731f6e-c3af-46ce-8e51-51a0495c568c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cardiac Function Laboratory |
| Version Model Number | CFL-M Inca |
| Catalog Number | CDL001 |
| Company DUNS | 414947457 |
| Company Name | CD Leycom |
| 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 | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08717953256645 [Primary] |
| DQO | Catheter, Intravascular, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-28 |
| Device Publish Date | 2023-09-20 |
| 08717953256645 - Cardiac Function Laboratory | 2023-09-28Inca PV loop system for the measurement of cardiac function and performance. |
| 08717953256645 - Cardiac Function Laboratory | 2023-09-28 Inca PV loop system for the measurement of cardiac function and performance. |
| 08719327737309 - 4 Fr PV Catheter | 2023-09-28 4 French PV Loop catheter with 6 mm electrode spacing |
| 08719327737316 - 4 Fr PV Catheter | 2023-09-28 4 Fr PV Loop catheter with 10 mm electrode spacing |
| 08719327737323 - 7 Fr PV-Catheter | 2023-09-28 7 French PV Loop Catheter with 8mm electrode spacing |
| 08719327737330 - 7 Fr PV-Catheter | 2023-09-28 7 Fr PV Loop catheter with 10 mm electrode spacing |
| 08719327737347 - 7 Fr PV-Catheter | 2023-09-28 7 Fr PV-Loop catheter with 12 mm electrode spacing |