| Primary Device ID | 00850008997051 |
| NIH Device Record Key | cd1abb1e-9b43-4a20-9c8b-0f4b3d7181a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cordella Data Analysis Platform |
| Version Model Number | 100543-00 |
| Company DUNS | 806850835 |
| Company Name | Endotronix, Inc. |
| 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 | 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 | 2024-08-21 myCordella Patient Management Portal is a component of the myCordella Patient Kit.
myCordella Patient Management Portal is a w |
| 00850008997051 - Cordella Data Analysis Platform | 2024-08-21The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Data Analysis Platform (CDAP) is a component of the Cordella Pulmonary Artery Sensor System.
The Cordella Data Analysis Platform (CDAP) is a secure, cloud-based, standalone application that collects and stores raw Reader data
and processes it according to pre-defined algorithms to convert it into final-form pulmonary artery pressure data. |
| 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 |