Endotronix, Inc.

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• endotronix.com

Registered Device Listings#

Product Codes Associated With Registrations#

GUDID#

• myCordella Patient App - myCordella 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

  Endotronix, Inc.

  2024-08-13

• myCordella Patient Management Portal - myCordella 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.

  Endotronix, Inc.

  2024-08-13

• myCordella Patient Kit - myCordella Patient Kit consists of the myCordella Tablet and PeripheralsmyCordella TabletAn intuitive, user-friendly display screen that assists patients with obtaining vital sign measurements.• Collects & securely transmits daily health information to doctors• Provides secure communication between patient and doctor• Provides access to patient education materials• Facilitates review of past measurements• Facilitates review of patient goalsmyCordella PeripheralsMedical or consumer health devices that measure blood pressure, heart rate, blood oxygen, and weight. The peripherals transmit information measured to the myCordella Tablet via wireless connection.

  Endotronix, Inc.

  2024-08-13

• myCordella Handheld Patient Reader Alloy - The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. myCordella Handheld Patient Reader is a component of the Cordella Pulmonary Artery Sensor System.The myCordella Handheld Patient Reader (Reader) is a handheld device that is provided to the patient for at-home use to measure PA pressure on demand. The Reader wirelessly transmits the raw data obtained from the Cordella Sensor to the myCordella Tablet. The raw data is converted into readable data and sent to the myCordella Patient Management Portal for the clinician to review.

  Endotronix, Inc.

  2025-10-13

• Cordella Sensor Delivery Kit - The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Sensor Delivery Kit consists of the Cordella PA Sensor and Delivery System which are components of the Cordella Pulmonary Artery Sensor System.Cordella PA SensorThe Cordella Sensor is a small implant that resides permanently in the patient’s right pulmonary artery. The Cordella Sensor does not contain batteries or active electrical components. The Cordella Sensor is not made with natural rubber latex.Delivery SystemThe Delivery System is a catheter with a pre-loaded Cordella Sensor at the distal end and is used to implant the Cordella Sensor into the right pulmonary artery. The Delivery System comprises a stability sheath, torque catheter, handle, torque luer, and side port. Implantation of the Cordella Sensor using the Delivery System is designed to be performed during right heart catheterization through venous access. The Stability Sheath contains a marker band at the distal end to aid in visualization under fluoroscopy. The Delivery System is not made with natural rubber latex.

  Endotronix, Inc.

  2024-08-14

• myCordella Handheld Patient Reader - The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. myCordella Handheld Patient Reader is a component of the Cordella Pulmonary Artery Sensor System.The myCordella Handheld Patient Reader (Reader) is a handheld device that is provided to the patient for at-home use to measure PA pressure on demand. The Reader wirelessly transmits the raw data obtained from the Cordella Sensor to the myCordella Tablet. The raw data is converted into readable data and sent to the myCordella Patient Management Portal for the clinician to review.

  Endotronix, Inc.

  2024-08-13

• Cordella Calibration Equipment - The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Calibration Equipment is a component of the Cordella Pulmonary Artery Sensor System.The Calibration Equipment (CalEQ) is hospital equipment that supports the implantation procedure. The main functions of Calibration Equipment include:• Interrogates the Cordella Sensor to verify proper working condition.• Facilitates linking of component serial numbers to patient IDs.• Calibrates the Cordella Sensor to a reference pressure at the time of implantation.• Trains patient on optimal Reader placement post-procedure.• Recalibrates the Cordella Sensor to a reference pressure post-implant.• CalEQ is operated by Endotronix personnel only.

  Endotronix, Inc.

  2024-08-13

• Cordella Data Analysis Platform - The 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 dataand processes it according to pre-defined algorithms to convert it into final-form pulmonary artery pressure data.

  Endotronix, Inc.

  2024-08-13