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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™ Courier™ - 05415067026187

Software Installation, 30 day trial, v.3.0
ST. JUDE MEDICAL, INC.
H702501-T
In Commercial Distribution

  • 05415067026187 ()
H702501-T

  • Cardiac mapping system application software

EnSite™ Courier™ - 05415067026170

Software Installation, v.3.0
ST. JUDE MEDICAL, INC.
H702501
In Commercial Distribution

  • 05415067026170 ()
H702501

  • Cardiac mapping system application software

EnSite™ - 05415067026163

Module, 30 day trial, v.1.0
ST. JUDE MEDICAL, INC.
AutoMap
In Commercial Distribution

  • 05415067026163 ()
H702498-T

  • Cardiac mapping system application software

AutoMark - 05415067026149

Software Installation, v.1.0
ST. JUDE MEDICAL, INC.
H702499
In Commercial Distribution

  • 05415067026149 ()
H702499

  • Cardiac mapping system application software

ScanNav Anatomy Peripheral Nerve Block - 05060878810052

ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD) which assists qualified healthcare professionals to identify anatomy in live ultrasound images. The Anatomy PNB receives scan images in real-time from a compatible general-purpose ultrasound machine. It then processes the images using deep learning artificial intelligence algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The original view from the ultrasound machine is not affected and is always available both on the ultrasound machine and the Anatomy PNB.
INTELLIGENT ULTRASOUND LIMITED
V2.0
Not in Commercial Distribution

  • 05060878810052 ()


  • Ultrasound imaging system application software

ScanNav Anatomy Peripheral Nerve Block - 05060878810021

ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD) which assists qualified healthcare professionals to identify anatomy in live ultrasound images. The Anatomy PNB receives scan images in real-time from a compatible general-purpose ultrasound machine. It then processes the images using deep learning artificial intelligence algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The original view from the ultrasound machine is not affected and is always available both on the ultrasound machine and the Anatomy PNB.
INTELLIGENT ULTRASOUND LIMITED
V1.1
Not in Commercial Distribution

  • 05060878810021 ()


  • Ultrasound imaging system application software

EnSite™ - 05415067003027

Software Installation
ST. JUDE MEDICAL, INC.
100037184
In Commercial Distribution

  • 05415067003027 ()
100037184

  • Cardiac mapping system application software

EnSite™ - 05415067002952

Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700295
In Commercial Distribution

  • 05415067002952 ()
H700295

  • Cardiac mapping system application software

EnSite™ - 05415067002938

Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700293
In Commercial Distribution

  • 05415067002938 ()
H700293

  • Cardiac mapping system application software

EnSite™ - 05415067002921

Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700292
In Commercial Distribution

  • 05415067002921 ()
H700292

  • Cardiac mapping system application software
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