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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Leadless Pacemaker
ST. JUDE MEDICAL, INC.
LSP202V
In Commercial Distribution

  • 05415067040725 ()
LSP202V

  • Intracardiac pacemaker
MerlinAtHome Software
ST. JUDE MEDICAL, INC.
EX2000
In Commercial Distribution

  • 05415067040404 ()
EX2000

  • Transtelephonic implantable pacemaker analysis system
Insertable Cardiac Monitor
ST. JUDE MEDICAL, INC.
DM4500
In Commercial Distribution

  • 05415067040046 ()
DM4500

  • Implantable cardiac monitor
X EP System Wave Speed Map Software License
ST. JUDE MEDICAL, INC.
ENSITE-WS-01
In Commercial Distribution

  • 05415067038111 ()
ENSITE-WS-01

  • Cardiac mapping system application software
Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-WS-01
In Commercial Distribution

  • 05415067038098 ()
ENSITE-D-WS-01

  • Cardiac mapping system application software
X EP System Omnipolar Technology Data Export Software License
ST. JUDE MEDICAL, INC.
ENSITE-OTEXPORT-01
In Commercial Distribution

  • 05415067037770 ()
ENSITE-OTEXPORT-01

  • Cardiac mapping system application software
Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-1.1
In Commercial Distribution

  • 05415067037763 ()
ENSITE-SW-1.1

  • Cardiac mapping system application software
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-1.1
In Commercial Distribution

  • 05415067037756 ()
ENSITE-R-DWS-1.1

  • Cardiac mapping system
X EP System LiveView Dynamic Display Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-LV-01
In Commercial Distribution

  • 05415067037749 ()
ENSITE-D-LV-01

  • Cardiac mapping system application software
X EP System Live Export Software License
ST. JUDE MEDICAL, INC.
ENSITE-LE-01
In Commercial Distribution

  • 05415067037732 ()
ENSITE-LE-01

  • Cardiac mapping system application software
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-1.1
In Commercial Distribution

  • 05415067037725 ()
ENSITE-DWS-1.1

  • Cardiac mapping system
X EP System LiveView Dynamic Display Software License
ST. JUDE MEDICAL, INC.
ENSITE-LV-01
In Commercial Distribution

  • 05415067037718 ()
ENSITE-LV-01

  • Cardiac mapping system application software
X EP System Omnipolar Technology Software License
ST. JUDE MEDICAL, INC.
ENSITE-OT-01
In Commercial Distribution

  • 05415067037701 ()
ENSITE-OT-01

  • Cardiac mapping system application software
X EP System Omnipolar Technology Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-OT-01
In Commercial Distribution

  • 05415067037695 ()
ENSITE-D-OT-01

  • Cardiac mapping system application software
Monitor Cable
ST. JUDE MEDICAL, INC.
C12849
In Commercial Distribution

  • 05415067037572 ()
C12849

  • Electrical-only medical device connection cable, reusable
2 PCS MER3400 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
MER3400
In Commercial Distribution

  • 05415067037121 ()
MER3400

  • Implantable cardiac device management application software
Next Doc Holster FRU
ST. JUDE MEDICAL, INC.
1014941
In Commercial Distribution

  • 05415067036810 ()
1014941

  • Coronary optical coherence tomography system
OPTISi Next Monitor
ST. JUDE MEDICAL, INC.
1014942
In Commercial Distribution

  • 05415067036728 ()
1014942

  • Coronary optical coherence tomography system
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-LG
In Commercial Distribution

  • 05415067036650 ()
NVTR-LS-LG

  • Self-expandable heart valve bioprosthesis collapsing tool, single-use
Mobile Next
ST. JUDE MEDICAL, INC.
1014937
In Commercial Distribution

  • 05415067036629 ()
1014937

  • Coronary optical coherence tomography system
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
Software Installation
ST. JUDE MEDICAL, INC.
H800011
In Commercial Distribution

  • 05415067035561 ()
H800011

  • Cardiac catheterization monitoring system
Slitter
ST. JUDE MEDICAL, INC.
DS3A001
In Commercial Distribution

  • 05415067035028 ()
DS3A001

  • Intravascular catheter slitter
Software Installation
ST. JUDE MEDICAL, INC.
H702701
In Commercial Distribution

  • 05415067035004 ()
H702701

  • Cardiac mapping system application software
Patient Controller App
ST. JUDE MEDICAL, INC.
55500
In Commercial Distribution

  • 05415067034977 ()
55500

  • Multiple active implantable device programmer
Clinician Programmer App
ST. JUDE MEDICAL, INC.
55600
In Commercial Distribution

  • 05415067034960 ()
55600

  • Multiple active implantable device programmer
Introducer Hydrophilic-Coated Introducer Sheath
ST. JUDE MEDICAL, INC.
LSN25501
In Commercial Distribution

  • 05415067034847 ()

  • Catheter Gauge: 25.0000 French
  • Outer Diameter: 8.9000 Millimeter
  • Length: 50.0000 Centimeter
LSN25501

  • Vascular catheter introduction set, nonimplantable
Introducer Hydrophilic-Coated Introducer Sheath
ST. JUDE MEDICAL, INC.
LSN25301
In Commercial Distribution

  • 05415067034823 ()

  • Outer Diameter: 8.9000 Millimeter
  • Catheter Gauge: 25.0000 French
  • Length: 30.0000 Centimeter
LSN25301

  • Vascular catheter introduction set, nonimplantable
Transmitter
ST. JUDE MEDICAL, INC.
EX1150W
In Commercial Distribution

  • 05415067034809 ()
EX1150W

  • Transtelephonic implantable pacemaker analysis system
X EP System Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-AMP-02
In Commercial Distribution

  • 05415067034755 ()
ENSITE-AMP-02

  • Cardiac mapping system
X EP System Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-R-AMP-02
In Commercial Distribution

  • 05415067034748 ()
ENSITE-R-AMP-02

  • Cardiac mapping system
IC Output Cable
ST. JUDE MEDICAL, INC.
ENSITE-WM56-60-01
In Commercial Distribution

  • 05415067033659 ()

  • Length: 152.0000 Centimeter
ENSITE-WM56-60-01

  • Electrical-only medical device connection cable, reusable
Triple Monitor Mount
ST. JUDE MEDICAL, INC.
ENSITE-TMMK-01
In Commercial Distribution

  • 05415067033635 ()
ENSITE-TMMK-01

  • Transportable medical equipment stand, non-powered
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