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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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Intera 3000 Hepatic Artery Infusion Pump and Operating Room Prep Kit
Intera Oncology Inc.
AP-03000H
In Commercial Distribution

  • 00850014110147 ()

  • Total Volume: 30 Milliliter
AP03000H

  • Implantable intrathecal infusion pump, nonprogrammable
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
Aorflex AAA Stent Graft Body with Aorflex Delivery System
LOMBARD MEDICAL LIMITED
SG-HBB-25-111-80-14-A12-22
In Commercial Distribution

  • 05055715607223 ()


  • Abdominal aorta endovascular stent-graft
Aorflex AAA Stent Graft Body with Aorflex Delivery System
LOMBARD MEDICAL LIMITED
SG-HBB-25-111-80-12-A12-22
In Commercial Distribution

  • 05055715607216 ()


  • Abdominal aorta endovascular stent-graft
Aorflex AAA Stent Graft Body with Aorflex Delivery System
LOMBARD MEDICAL LIMITED
SG-HBB-25-111-80-10-A12-22
In Commercial Distribution

  • 05055715607209 ()


  • Abdominal aorta endovascular stent-graft
Aorflex AAA Stent Graft Body with Aorflex Delivery System
LOMBARD MEDICAL LIMITED
SG-HBB-25-111-63-20-A12-22
In Commercial Distribution

  • 05055715607193 ()


  • Abdominal aorta endovascular stent-graft
Aorflex AAA Stent Graft Body with Aorflex Delivery System
LOMBARD MEDICAL LIMITED
SG-HBB-25-111-63-18-A12-22
In Commercial Distribution

  • 05055715607186 ()


  • Abdominal aorta endovascular stent-graft
Aorflex AAA Stent Graft Body with Aorflex Delivery System
LOMBARD MEDICAL LIMITED
SG-HBB-25-111-63-16-A12-22
In Commercial Distribution

  • 05055715607179 ()


  • Abdominal aorta endovascular stent-graft
Aorflex AAA Stent Graft Body with Aorflex Delivery System
LOMBARD MEDICAL LIMITED
SG-HBB-25-111-63-14-A12-22
In Commercial Distribution

  • 05055715607162 ()


  • Abdominal aorta endovascular stent-graft
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