myCordella Handheld Patient Reader

GUDID 00850008997013

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.

Implantable pulmonary artery pressure monitoring system

• Primary Device ID: 00850008997013
• NIH Device Record Key: 1519373d-3597-4fd2-a2dd-095bba80fdfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: myCordella Handheld Patient Reader
• Version Model Number: 100102-01
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 6 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 6 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 6 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 6 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 6 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 6 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 6 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 6 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 6 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 6 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 6 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 6 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 6 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 6 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 6 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 6 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 6 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850008997013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P230040

FDA Product Code

• MOM: System, Hemodynamic, Implantable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-21
• Device Publish Date: 2024-08-13

Devices Manufactured by Endotronix, Inc.

• 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: 2024-08-21The 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.
• 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: 2024-08-21 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