| Primary Device ID | 00850008997044 |
| NIH Device Record Key | 2f107dfb-5b1a-47e8-a52e-a7efc178debe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | myCordella Patient Management Portal |
| Version Model Number | 100258-00 |
| Company DUNS | 806850835 |
| Company Name | Endotronix, 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 | false |
| 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 |
| 00850008997006 - Cordella Sensor Delivery Kit | 2024-08-22 The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patientâ |
| 00850008997013 - myCordella Handheld Patient Reader | 2024-08-21 The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patientâ |
| 00850008997020 - Cordella Calibration Equipment | 2024-08-21 The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patientâ |
| 00850008997037 - myCordella Patient App | 2024-08-21 myCordella Patient App is a component of the myCordella Patient Kit.
myCordella Patient App is an intuitive, user-friendly softw |
| 00850008997044 - myCordella Patient Management Portal | 2024-08-21myCordella Patient Management Portal is a component of the myCordella Patient Kit.
myCordella Patient Management Portal is a web-based application that displays patient data received from the myCordella Tablet to the clinician. The PMP is intended to assist clinicians in managing patients. |
| 00850008997044 - myCordella Patient Management Portal | 2024-08-21 myCordella Patient Management Portal is a component of the myCordella Patient Kit.
myCordella Patient Management Portal is a w |
| 00850008997051 - Cordella Data Analysis Platform | 2024-08-21 The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patientâ |
| 00850008997068 - myCordella Patient Kit | 2024-08-21 myCordella Patient Kit consists of the myCordella Tablet and Peripherals
myCordella Tablet
An intuitive, user-friendly display s |