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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Monitor Pole
ST. JUDE MEDICAL, INC.
ENSITE-MONPOLE-01
In Commercial Distribution

  • 05415067033574 ()
ENSITE-MONPOLE-01

  • Transportable medical equipment stand, non-powered
Fixed Field Frame Bracket
ST. JUDE MEDICAL, INC.
ENSITE-FF-BRCKT-01
In Commercial Distribution

  • 05415067033567 ()
ENSITE-FF-BRCKT-01

  • Medical table clamp
Adjustable Field Frame Bracket
ST. JUDE MEDICAL, INC.
ENSITE-FF-ABRKT-01
In Commercial Distribution

  • 05415067033550 ()
ENSITE-FF-ABRKT-01

  • Medical table clamp
Radio-opaque ECG Lead Set
ST. JUDE MEDICAL, INC.
ENSITE-ECGRO-01
In Commercial Distribution

  • 05415067033536 ()

  • Length: 152.0000 Centimeter
ENSITE-ECGRO-01

  • Electrical-only medical device connection cable, reusable
Radio-lucent ECG Lead Set
ST. JUDE MEDICAL, INC.
ENSITE-ECGRL-01
In Commercial Distribution

  • 05415067033512 ()

  • Length: 152.0000 Centimeter
ENSITE-ECGRL-01

  • Electrical-only medical device connection cable, reusable
X EP System ECG Output Module
ST. JUDE MEDICAL, INC.
ENSITE-ECGOUT-01
In Commercial Distribution

  • 05415067033499 ()
ENSITE-ECGOUT-01

  • Electrical-only medical device connection adaptor, reusable
Display Workstation Cart
ST. JUDE MEDICAL, INC.
ENSITE-DWSCART-01
In Commercial Distribution

  • 05415067033482 ()
ENSITE-DWSCART-01

  • Electromechanical device/system transport trolley
Dual Monitor Mount
ST. JUDE MEDICAL, INC.
ENSITE-DMMK-01
In Commercial Distribution

  • 05415067033475 ()
ENSITE-DMMK-01

  • Transportable medical equipment stand, non-powered
Recording System IC Output Cable
ST. JUDE MEDICAL, INC.
ENSITE-CR-64-01
In Commercial Distribution

  • 05415067033468 ()
ENSITE-CR-64-01

  • Electrical-only medical device connection cable, reusable
Recording System IC Output Cable
ST. JUDE MEDICAL, INC.
ENSITE-CR-56-01
In Commercial Distribution

  • 05415067033451 ()
ENSITE-CR-56-01

  • Electrical-only medical device connection cable, reusable
Catheter Input Module
ST. JUDE MEDICAL, INC.
ENSITE-CIM-80-01
In Commercial Distribution

  • 05415067033444 ()
ENSITE-CIM-80-01

  • Electrical-only medical device connection adaptor, reusable
X EP System Catheter Input Module
ST. JUDE MEDICAL, INC.
ENSITE-CIM-20-01
In Commercial Distribution

  • 05415067033437 ()
ENSITE-CIM-20-01

  • Electrical-only medical device connection adaptor, reusable
ECG Cable
ST. JUDE MEDICAL, INC.
ENSITE-CECG-60-01
In Commercial Distribution

  • 05415067033420 ()

  • Length: 152.0000 Centimeter
ENSITE-CECG-60-01

  • Electrical-only medical device connection cable, reusable
ECG Cable
ST. JUDE MEDICAL, INC.
ENSITE-CECG-144-01
In Commercial Distribution

  • 05415067033413 ()

  • Length: 366.0000 Centimeter
ENSITE-CECG-144-01

  • Electrical-only medical device connection cable, reusable
Amplifier Cart
ST. JUDE MEDICAL, INC.
ENSITE-AMPCART3-01
In Commercial Distribution

  • 05415067033406 ()
ENSITE-AMPCART3-01

  • Electromechanical device/system transport trolley
Amplifier Cart
ST. JUDE MEDICAL, INC.
ENSITE-AMPCART1-01
In Commercial Distribution

  • 05415067033390 ()
ENSITE-AMPCART1-01

  • Electromechanical device/system transport trolley
Connect Cable
ST. JUDE MEDICAL, INC.
ENSITE-ACBL-60-01
In Commercial Distribution

  • 05415067033383 ()

  • Length: 152.0000 Centimeter
ENSITE-ACBL-60-01

  • Electrical-only medical device connection cable, reusable
Connect Cable
ST. JUDE MEDICAL, INC.
ENSITE-ACBL-160-01
In Commercial Distribution

  • 05415067033376 ()

  • Length: 406.0000 Centimeter
ENSITE-ACBL-160-01

  • Electrical-only medical device connection cable, reusable
Delivery Sheath
ST. JUDE MEDICAL, INC.
9-TDS-09F45-80
In Commercial Distribution

  • 05415067033369 ()

  • Length: 80.0000 Centimeter
  • Catheter Gauge: 9.0000 French
9-TDS-09F45-80

  • Cardiac occluder delivery kit
Delivery Sheath
ST. JUDE MEDICAL, INC.
9-TDS-08F45-80
In Commercial Distribution

  • 05415067033352 ()

  • Length: 80.0000 Centimeter
  • Catheter Gauge: 8.0000 French
9-TDS-08F45-80

  • Cardiac occluder delivery kit
PFO Occluder
ST. JUDE MEDICAL, INC.
9-PFO-3525
In Commercial Distribution

  • 05415067033345 ()

  • Catheter Gauge: 9.0000 French
  • Outer Diameter: 35.0000 Millimeter
9-PFO-3525

  • Cardiac defect occluder
PFO Occluder
ST. JUDE MEDICAL, INC.
9-PFO-3025
In Commercial Distribution

  • 05415067033321 ()

  • Outer Diameter: 30.0000 Millimeter
  • Catheter Gauge: 9.0000 French
9-PFO-3025

  • Cardiac defect occluder
PFO Occluder
ST. JUDE MEDICAL, INC.
9-PFO-2518
In Commercial Distribution

  • 05415067033314 ()

  • Catheter Gauge: 8.0000 French
  • Outer Diameter: 25.0000 Millimeter
9-PFO-2518

  • Cardiac defect occluder
PFO Occluder
ST. JUDE MEDICAL, INC.
9-PFO-1818
In Commercial Distribution

  • 05415067033307 ()

  • Outer Diameter: 18.0000 Millimeter
  • Catheter Gauge: 8.0000 French
9-PFO-1818

  • Cardiac defect occluder
Patient Reference Sensor
ST. JUDE MEDICAL, INC.
ENSITE-PRSBACK-01
In Commercial Distribution

  • 05415067033291 ()
ENSITE-PRSBACK-01

  • Patient positioning sensor
Patient Reference Sensor
ST. JUDE MEDICAL, INC.
ENSITE-PRSFRNT-01
In Commercial Distribution

  • 05415067033284 ()
ENSITE-PRSFRNT-01

  • Patient positioning sensor
Software License
ST. JUDE MEDICAL, INC.
H702601
In Commercial Distribution

  • 05415067033185 ()
H702601

  • Cardiac mapping system application software
System Software Upgrade
ST. JUDE MEDICAL, INC.
H702602
In Commercial Distribution

  • 05415067033178 ()
H702602

  • Cardiac mapping system application software
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
ESP200-27
In Commercial Distribution

  • 05415067033154 ()
ESP200-27

  • Aortic open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
ESP200-25
In Commercial Distribution

  • 05415067033147 ()
ESP200-25

  • Aortic open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
ESP200-23
In Commercial Distribution

  • 05415067033130 ()
ESP200-23

  • Aortic open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
ESP200-21
In Commercial Distribution

  • 05415067033123 ()
ESP200-21

  • Aortic open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
ESP200-19
In Commercial Distribution

  • 05415067033116 ()
ESP200-19

  • Aortic open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-33M
In Commercial Distribution

  • 05415067033109 ()
E200-33M

  • Mitral open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-31M
In Commercial Distribution

  • 05415067033093 ()
E200-31M

  • Mitral open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-29M
In Commercial Distribution

  • 05415067033086 ()
E200-29M

  • Mitral open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-29A
In Commercial Distribution

  • 05415067033079 ()
E200-29A

  • Aortic open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-27M
In Commercial Distribution

  • 05415067033062 ()
E200-27M

  • Mitral open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-27A
In Commercial Distribution

  • 05415067033055 ()
E200-27A

  • Aortic open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-25M
In Commercial Distribution

  • 05415067033048 ()
E200-25M

  • Mitral open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-25A
In Commercial Distribution

  • 05415067033031 ()
E200-25A

  • Aortic open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-23A
In Commercial Distribution

  • 05415067033024 ()
E200-23A

  • Aortic open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-21A
In Commercial Distribution

  • 05415067033017 ()
E200-21A

  • Aortic open-surgery heart valve bioprosthesis
HF Cardiac Resychronisation Therapy Defibrillator VVED DDDRV
ST. JUDE MEDICAL, INC.
CDHFA300Q
In Commercial Distribution

  • 05415067032850 ()
CDHFA300Q

  • Cardiac resynchronization therapy implantable defibrillator
DR Implantable Cardioverter Defibrillator VVED DDDR
ST. JUDE MEDICAL, INC.
CDDRA300Q
In Commercial Distribution

  • 05415067032843 ()
CDDRA300Q

  • Dual-chamber implantable defibrillator
VR Implantable Cardioverter Defibrillator VVEV VVIR
ST. JUDE MEDICAL, INC.
CDVRA300Q
In Commercial Distribution

  • 05415067032836 ()
CDVRA300Q

  • Single-chamber implantable defibrillator
Mobile application compatible to iOS operating system
ST. JUDE MEDICAL, INC.
APP1005
In Commercial Distribution

  • 05415067032829 ()
APP1005

  • Implantable cardiac device management application software
Mobile application compatible to Android operating system
ST. JUDE MEDICAL, INC.
APP1004
In Commercial Distribution

  • 05415067032812 ()
APP1004

  • Implantable cardiac device management application software
Stand Components
ST. JUDE MEDICAL, INC.
TENDV-SC
In Commercial Distribution

  • 05415067032720 ()
TENDV-SC

  • Self-expandable heart valve bioprosthesis collapsing tool, single-use
Pad Positioning System
ST. JUDE MEDICAL, INC.
TENDV-PS
In Commercial Distribution

  • 05415067032713 ()
TENDV-PS

  • Mitral transcatheter heart valve bioprosthesis
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