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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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EnSite™ Velocity™ - 05415067001061

DWS Kit
ST. JUDE MEDICAL, INC.
100052576
In Commercial Distribution

  • 05415067001061 ()
100052576

  • Cardiac mapping system

EnSite™ - 05415067001054

Display Workstation (DWS)
ST. JUDE MEDICAL, INC.
100027826
In Commercial Distribution

  • 05415067001054 ()
100027826

  • Cardiac mapping system

EP-NurseMate™ - 05415067000972

No Description
ST. JUDE MEDICAL, INC.
H700097
In Commercial Distribution

  • 05415067000972 ()
H700097

  • Cardiac catheterization monitoring system

EP-WorkMate™ - 05415067000965

No Description
ST. JUDE MEDICAL, INC.
Recording System
In Commercial Distribution

  • 05415067000965 ()
H700096

  • Cardiac catheterization monitoring system

EnSite™ - 05415067000910

Display Workstation
ST. JUDE MEDICAL, INC.
EE3000
In Commercial Distribution

  • 05415067000910 ()
EE3000

  • Cardiac mapping system

WorkMate™ - 05415067000897

CI Module 2
ST. JUDE MEDICAL, INC.
H700089
In Commercial Distribution

  • 05415067000897 ()
H700089

  • Cardiac catheterization monitoring system

WorkMate™ - 05415067000880

CI Module 1
ST. JUDE MEDICAL, INC.
H700088
In Commercial Distribution

  • 05415067000880 ()
H700088

  • Cardiac catheterization monitoring system

EP-WorkMate™ - 05415067000866

Software Upgrade Kit v.4.3.2
ST. JUDE MEDICAL, INC.
H700086
In Commercial Distribution

  • 05415067000866 ()
H700086

  • Cardiac catheterization monitoring system

MediGuide™ - 05415067000712

PRS Patch
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 15415067000719 ()
  • 05415067000712 ()
H700071

  • Cardiac mapping system

EnSite™ - 05415067000026

GenConnect Module Generator Connector
ST. JUDE MEDICAL, INC.
H00002
In Commercial Distribution

  • 05415067000026 ()
H00002

  • Electrical-only medical device connection cable, reusable
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