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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Aortic Valved Graft with Hemashield Graft technology Mechanical Valved Graft
ST. JUDE MEDICAL, INC.
19CAVGJ-514 00
In Commercial Distribution


  • Outer Diameter: 19.0000 Millimeter
19CAVGJ-514 00

  • Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft
HP Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
27AEHPJ-505
In Commercial Distribution


  • Outer Diameter: 27.0000 Millimeter
27AEHPJ-505

  • Aortic bi-leaflet mechanical heart valve prosthesis
HP Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
25AEHPJ-505
In Commercial Distribution


  • Outer Diameter: 25.0000 Millimeter
25AEHPJ-505

  • Aortic bi-leaflet mechanical heart valve prosthesis
HP Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
23AEHPJ-505
In Commercial Distribution


  • Outer Diameter: 23.0000 Millimeter
23AEHPJ-505

  • Aortic bi-leaflet mechanical heart valve prosthesis
HP Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
21AEHPJ-505
In Commercial Distribution


  • Outer Diameter: 21.0000 Millimeter
21AEHPJ-505

  • Aortic bi-leaflet mechanical heart valve prosthesis
HP Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
17AEHPJ-505
In Commercial Distribution


  • Outer Diameter: 17.0000 Millimeter
17AEHPJ-505

  • Aortic bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
27MHPJ-505
In Commercial Distribution


  • Outer Diameter: 27.0000 Millimeter
27MHPJ-505

  • Mitral bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
25MHPJ-505
In Commercial Distribution


  • Outer Diameter: 25.0000 Millimeter
25MHPJ-505

  • Mitral bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
23MHPJ-505
In Commercial Distribution


  • Outer Diameter: 23.0000 Millimeter
23MHPJ-505

  • Mitral bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
21MHPJ-505
In Commercial Distribution


  • Outer Diameter: 21.0000 Millimeter
21MHPJ-505

  • Mitral bi-leaflet mechanical heart valve prosthesis
HP Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
19MHPJ-505
In Commercial Distribution


  • Outer Diameter: 19.0000 Millimeter
19MHPJ-505

  • Mitral bi-leaflet mechanical heart valve prosthesis
Aortic Valved Graft with Hemashield Graft technology Mechanical Valved Graft
ST. JUDE MEDICAL, INC.
33CAVGJ-514 00
In Commercial Distribution


  • Outer Diameter: 33.0000 Millimeter
33CAVGJ-514 00

  • Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft
HP Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
17MHPJ-505
In Commercial Distribution


  • Outer Diameter: 17.0000 Millimeter
17MHPJ-505

  • Mitral bi-leaflet mechanical heart valve prosthesis
HP Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
27AHPJ-505
In Commercial Distribution


  • Outer Diameter: 27.0000 Millimeter
27AHPJ-505

  • Aortic bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
21MTJ-503
In Commercial Distribution


  • Outer Diameter: 21.0000 Millimeter
21MTJ-503

  • Mitral bi-leaflet mechanical heart valve prosthesis
HP Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
15MHPJ-505
In Commercial Distribution


  • Outer Diameter: 15.0000 Millimeter
15MHPJ-505

  • Mitral bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
27AECJ-502
In Commercial Distribution


  • Outer Diameter: 27.0000 Millimeter
27AECJ-502

  • Aortic bi-leaflet mechanical heart valve prosthesis
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405254
In Commercial Distribution

  • 15415067041255 ()
  • 05415067041258 ()
  • 05414734204590 ()

  • Catheter Gauge: 9.0000 French
  • Length: 23.0000 Centimeter
405254

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405154
In Commercial Distribution


  • Length: 14.0000 Centimeter
  • Catheter Gauge: 7.0000 French
405154

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405153
In Commercial Distribution


  • Catheter Gauge: 7.0000 French
  • Length: 14.0000 Centimeter
405153

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405149
In Commercial Distribution


  • Catheter Gauge: 10.0000 French
  • Length: 14.0000 Centimeter
405149

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405147
In Commercial Distribution


  • Length: 14.0000 Centimeter
  • Catheter Gauge: 9.0000 French
405147

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405146
In Commercial Distribution


  • Catheter Gauge: 8.5000 French
  • Length: 14.0000 Centimeter
405146

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405145
In Commercial Distribution


  • Length: 14.0000 Centimeter
  • Catheter Gauge: 8.0000 French
405145

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405144
In Commercial Distribution

  • 15415067041095 ()
  • 05415067041098 ()
  • 05414734204347 ()

  • Length: 14.0000 Centimeter
  • Catheter Gauge: 16.0000 French
405144

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405136
In Commercial Distribution

  • 15415067041071 ()
  • 05415067041074 ()
  • 05414734204323 ()

  • Catheter Gauge: 14.0000 French
  • Length: 14.0000 Centimeter
405136

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405129
In Commercial Distribution

  • 15415067041057 ()
  • 05415067041050 ()
  • 05415067020970 ()

  • Catheter Gauge: 8.0000 French
  • Length: 14.0000 Centimeter
405129

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405128
In Commercial Distribution

  • 15415067041033 ()
  • 05415067041036 ()
  • 05415067020963 ()

  • Catheter Gauge: 12.0000 French
  • Length: 14.0000 Centimeter
405128

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405124
In Commercial Distribution

  • 15415067041019 ()
  • 05415067041012 ()
  • 05414734204248 ()

  • Catheter Gauge: 11.0000 French
  • Length: 14.0000 Centimeter
405124

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405122
In Commercial Distribution

  • 15415067040999 ()
  • 05415067040992 ()
  • 05414734204224 ()

  • Length: 14.0000 Centimeter
  • Catheter Gauge: 10.5000 French
405122

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405120
In Commercial Distribution

  • 15415067040975 ()
  • 05415067040978 ()
  • 05414734204200 ()

  • Length: 14.0000 Centimeter
  • Catheter Gauge: 10.0000 French
405120

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405119
In Commercial Distribution

  • 15415067040951 ()
  • 05415067040954 ()
  • 05415067020918 ()

  • Catheter Gauge: 8.5000 French
  • Length: 14.0000 Centimeter
405119

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405118
In Commercial Distribution

  • 15415067040937 ()
  • 05415067040930 ()
  • 05414734204163 ()

  • Catheter Gauge: 9.5000 French
  • Length: 14.0000 Centimeter
405118

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405116
In Commercial Distribution

  • 15415067040913 ()
  • 05415067040916 ()
  • 05414734204149 ()

  • Catheter Gauge: 9.0000 French
  • Length: 14.0000 Centimeter
405116

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405112
In Commercial Distribution

  • 15415067040890 ()
  • 05415067040893 ()
  • 05414734204125 ()

  • Catheter Gauge: 8.0000 French
  • Length: 14.0000 Centimeter
405112

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405108
In Commercial Distribution

  • 15415067040876 ()
  • 05415067040879 ()
  • 05414734204101 ()

  • Length: 14.0000 Centimeter
  • Catheter Gauge: 7.0000 French
405108

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405104
In Commercial Distribution

  • 15415067040852 ()
  • 05415067040855 ()
  • 05414734204088 ()

  • Catheter Gauge: 6.0000 French
  • Length: 14.0000 Centimeter
405104

  • Vascular catheter introduction set, nonimplantable
OPTISm Next DOC
ST. JUDE MEDICAL, INC.
1014939
In Commercial Distribution

  • 05415067036681 ()
1014939

  • Coronary optical coherence tomography system
Loading System
ST. JUDE MEDICAL, INC.
NVTR-LS-SM
In Commercial Distribution

  • 05415067036667 ()
NVTR-LS-SM

  • Self-expandable heart valve bioprosthesis collapsing tool, single-use
Loading System
ST. JUDE MEDICAL, INC.
NVTR-LS-LG
In Commercial Distribution

  • 05415067036650 ()
NVTR-LS-LG

  • Self-expandable heart valve bioprosthesis collapsing tool, single-use
Integrated Next
ST. JUDE MEDICAL, INC.
1014938
In Commercial Distribution

  • 05415067036643 ()
1014938

  • Coronary optical coherence tomography system
Mobile Next
ST. JUDE MEDICAL, INC.
1014937
In Commercial Distribution

  • 05415067036629 ()
1014937

  • Coronary optical coherence tomography system
PRE-CONNECTED PACK
ST. JUDE MEDICAL, INC.
CMAEK00
In Commercial Distribution

  • 05415067036414 ()
CMAEK00

  • Cardiopulmonary bypass system priming set
  • Cardiopulmonary bypass system centrifugal pump
Delivery Catheter
ST. JUDE MEDICAL, INC.
LSCD111
In Commercial Distribution

  • 05415067036384 ()

  • Outer Diameter: 6.8000 Millimeter
  • Length: 105.0000 Centimeter
LSCD111

  • Vascular guide-catheter, single-use
Steerable Delivery Sheath
ST. JUDE MEDICAL, INC.
ASDS-14F-075
Not in Commercial Distribution

  • 05415067036025 ()

  • Length: 75.0000 Centimeter
ASDS-14F-075

  • Cardiac occluder delivery kit
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800012
In Commercial Distribution

  • 05415067035615 ()
H800012

  • Cardiac catheterization monitoring system
Software Installation
ST. JUDE MEDICAL, INC.
H800009
In Commercial Distribution

  • 05415067035608 ()
H800009

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800008
In Commercial Distribution

  • 05415067035592 ()
H800008

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800007
In Commercial Distribution

  • 05415067035585 ()
H800007

  • Cardiac catheterization monitoring system
Software Installation
ST. JUDE MEDICAL, INC.
H800010
In Commercial Distribution

  • 05415067035578 ()
H800010

  • Cardiac catheterization monitoring system
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