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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™ - 05415067048400

X EP System Averaged Impedance Drop Software License
ST. JUDE MEDICAL, INC.
ENSITE-IMP-01
In Commercial Distribution

  • 05415067048400 ()
ENSITE-IMP-01

  • Cardiac mapping system application software

EnSite™ - 05415067048363

X EP System AutoMark Distance Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-AMD-01
In Commercial Distribution

  • 05415067048363 ()
ENSITE-D-AMD-01

  • Cardiac mapping system application software

EnSite™ - 05415067042477

X EP System Advanced Mapping Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-AM-2.0
In Commercial Distribution

  • 05415067042477 ()
ENSITE-D-AM-2.0

  • Cardiac mapping system application software

EnSite™ - 05415067038111

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

EnSite™ - 05415067037718

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

EnSite™ - 05415067037695

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

LiDCO - 05060110523054

Licence, Software, LiDCOrapid (Rapid, CNAP, BIS, Ext), Quarterly
LIDCO LIMITED
Li11076Q
In Commercial Distribution

  • 05060110523054 ()
Li11076Q

  • General-purpose multi-parameter bedside monitor

LiDCO - 05060110523047

Licence, Software, LiDCOrapid (Rapid, CNAP, BIS, Ext), Monthly
LIDCO LIMITED
Li11076M
In Commercial Distribution

  • 05060110523047 ()
Li11076M

  • General-purpose multi-parameter bedside monitor

LiDCO - 05060110523023

Licence, Software, LiDCOrapid (Rapid, CNAP, BIS, Ext), Annual
LIDCO LIMITED
Li11076A
In Commercial Distribution

  • 05060110523023 ()
Li11076A

  • General-purpose multi-parameter bedside monitor

OnPoint Surgical Cart - 00850051682485

OnPoint Surgical Cart (with pre-installed software) - 2 headsets
OnPoint Surgical, Inc.
1
In Commercial Distribution

  • 00850051682485 ()
NK0210301

  • Orthopaedic stereotactic surgery system
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