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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Power Cord Clip
ST. JUDE MEDICAL, INC.
CM3024
In Commercial Distribution

  • 05414734509909 ()
CM3024

  • Implantable pulmonary artery pressure monitoring system
Patient Electronics System
CARDIOMEMS, INC.
CM1100
In Commercial Distribution

  • 05414734509800 ()
CM1100

  • Implantable pulmonary artery pressure monitoring system
Power Supply
ST. JUDE MEDICAL, INC.
CM3022
In Commercial Distribution

  • 05414734509312 ()
CM3022

  • Implantable pulmonary artery pressure monitoring system
Printer Paper
ST. JUDE MEDICAL, INC.
CM3013
In Commercial Distribution

  • 05414734509282 ()
CM3013

  • Implantable pulmonary artery pressure monitoring system
Printer Power Cables
ST. JUDE MEDICAL, INC.
CM3012
In Commercial Distribution

  • 05414734509275 ()
CM3012

  • Implantable pulmonary artery pressure monitoring system
Pillow
ST. JUDE MEDICAL, INC.
CM1030
In Commercial Distribution

  • 05414734509190 ()
CM1030

  • Implantable pulmonary artery pressure monitoring system
No Description
CARDIOMEMS, INC.
CM1010
In Commercial Distribution

  • 05414734509176 ()
CM1010

  • 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 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 data and processes it according to pre-defined algorithms to convert it into final-form pulmonary artery pressure data.
Endotronix, Inc.
100543-00
In Commercial Distribution

  • 00850008997051 ()


  • 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 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. 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
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