| Primary Device ID | 00850008997037 |
| NIH Device Record Key | 0996a708-0aae-4d9e-9f96-f7995d9e82ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | myCordella Patient App |
| Version Model Number | 100256-02 |
| 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 |
| Phone | +1 888 512 5595 |
| support@endotronix.com | |
| Phone | +1 888 512 5595 |
| support@endotronix.com | |
| Phone | +1 888 512 5595 |
| support@endotronix.com | |
| Phone | +1 888 512 5595 |
| support@endotronix.com | |
| Phone | +1 888 512 5595 |
| support@endotronix.com | |
| Phone | +1 888 512 5595 |
| support@endotronix.com | |
| Phone | +1 888 512 5595 |
| support@endotronix.com | |
| Phone | +1 888 512 5595 |
| support@endotronix.com | |
| Phone | +1 888 512 5595 |
| support@endotronix.com | |
| Phone | +1 888 512 5595 |
| support@endotronix.com | |
| Phone | +1 888 512 5595 |
| support@endotronix.com | |
| Phone | +1 888 512 5595 |
| support@endotronix.com | |
| Phone | +1 888 512 5595 |
| support@endotronix.com | |
| Phone | +1 888 512 5595 |
| support@endotronix.com | |
| Phone | +1 888 512 5595 |
| support@endotronix.com | |
| Phone | +1 888 512 5595 |
| support@endotronix.com | |
| Phone | +1 888 512 5595 |
| support@endotronix.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850008997037 [Primary] |
| OEZ | Cardiovascular Procedure Kit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-21 |
| Device Publish Date | 2024-08-13 |
| 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 | 2024-08-21myCordella Patient App is a component of the myCordella Patient Kit. myCordella Patient App is an intuitive, user-friendly software that assists patients with obtaining vital sign measurements. • Collects & securely transmits daily health information to clinicians • Facilitates review of past measurements • Allows secure communication between patient and clinician |
| 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 | 2024-08-21 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 |