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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.
100622-00
In Commercial Distribution
- 00850008997020 ()
- Implantable pulmonary artery pressure monitoring system
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.
100102-01
In Commercial Distribution
- 00850008997013 ()
- Implantable pulmonary artery pressure monitoring system
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 Sensor
The 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 System
The 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.
100303-05
In Commercial Distribution
- 00850008997006 ()
- Implantable pulmonary artery pressure monitoring system
PUMP MMT-751PNAS PRDGM V1.1 SK US PW
MEDTRONIC MINIMED, INC.
MMT-751PNAS
In Commercial Distribution
- 00643169246157 ()
- Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm
PUMP MMT-751PNAP PRDGM V1.1 PL US PW
MEDTRONIC MINIMED, INC.
MMT-751PNAP
In Commercial Distribution
- 00643169246140 ()
- Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm
PUMP MMT-751PNAL PRDGM V1.1 CL US PW
MEDTRONIC MINIMED, INC.
MMT-751PNAL
In Commercial Distribution
- 00643169246133 ()
- Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm
PUMP MMT-751PNAH PRDGM V1.1 PINK US PW
MEDTRONIC MINIMED, INC.
MMT-751PNAH
In Commercial Distribution
- 00643169246126 ()
- Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm
PUMP MMT-751PNAB PRDGM V1.1 BL US PW
MEDTRONIC MINIMED, INC.
MMT-751PNAB
In Commercial Distribution
- 00643169246119 ()
- Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm
PUMP MMT-551PNAS PRDGM V1.1 SK US PW
MEDTRONIC MINIMED, INC.
MMT-551PNAS
In Commercial Distribution
- 00643169246102 ()
- Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm
PUMP MMT-551PNAP PRDGM V1.1 PL US PW
MEDTRONIC MINIMED, INC.
MMT-551PNAP
In Commercial Distribution
- 00643169246096 ()
- Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm