Cordella Calibration Equipment

GUDID 00850008997020

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.

Implantable pulmonary artery pressure monitoring system

• Primary Device ID: 00850008997020
• NIH Device Record Key: 651126b8-5057-45b1-8a43-24072b37d9db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cordella Calibration Equipment
• Version Model Number: 100622-00
• 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: 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 -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850008997020 [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: 2024-08-21 The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patientâ
• 00850008997020 - Cordella Calibration Equipment: 2024-08-21The 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.
• 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