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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™ - 05415067051097

X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-02
In Commercial Distribution

  • 05415067051097 ()
ENSITE-D-FWV-02

  • Cardiac mapping system application software

EnSite™ - 05415067050281

X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-01
In Commercial Distribution

  • 05415067050281 ()
ENSITE-D-FWV-01

  • Cardiac mapping system application software

EnSite™ - 05415067048394

X EP System EnSite VoXel Flex Mode Software License
ST. JUDE MEDICAL, INC.
ENSITE-FLEX-01
In Commercial Distribution

  • 05415067048394 ()
ENSITE-FLEX-01

  • Cardiac mapping system application software

EnSite™ - 05415067048370

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

  • 05415067048370 ()
ENSITE-D-IMP-01

  • Cardiac mapping system application software

EnSite™ - 05415067047861

X EP System TactiFlex Ablation Cath, SE Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-03
In Commercial Distribution

  • 05415067047861 ()
ENSITE-TFM-03

  • Cardiac mapping system application software

EnSite™ - 05415067046659

X EP System TactiFlex Ablation Catheter, SE Software License
ST. JUDE MEDICAL, INC.
ENSITE-TF-02
In Commercial Distribution

  • 05415067046659 ()
ENSITE-TF-02

  • Cardiac mapping system application software

ABACUS - 05413765577369

ABACUS Order Entry & Calculation Software versions 3.3.x ME
BAXTER HEALTHCARE CORPORATION
83003393
In Commercial Distribution

  • 05413765577369 ()
83003393

  • Intravenous solution compounder

ABACUS - 05413765577352

ABACUS ORDER ENTRY & CALCULATION SOFTWARE VERSIONS 3.3.X SE
BAXTER HEALTHCARE CORPORATION
83003392
In Commercial Distribution

  • 05413765577352 ()
83003392

  • Intravenous solution compounder

ABACUS - 05413765577345

ABACUS Order Entry & Calculation Software versions 3.3.x CE
BAXTER HEALTHCARE CORPORATION
83003391
In Commercial Distribution

  • 05413765577345 ()
83003391

  • Intravenous solution compounder

ABACUS - 05413765577321

ABACUS Order Entry & Calculation Software versions 3.3.x DE
BAXTER HEALTHCARE CORPORATION
83003390
In Commercial Distribution

  • 05413765577321 ()
83003390

  • Intravenous solution compounder
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