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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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t:connect Mobile Application, Mobile Bolus Enabled (Android) - 90850018992445

t:connect Mobile Application, Mobile Bolus Enabled, 2.x (Android)
Tandem Diabetes Care, Inc.
1007112
In Commercial Distribution

  • 90850018992445 ()


  • Ambulatory insulin infusion pump software, data-display
  • Ambulatory insulin infusion pump remote control

Prometra Programmer - 00810335020129

The Prometra Programmer is a non-sterile handheld menu driven device, external to the implanted pump that enables remote programming of the Prometra pump.
Flowonix Medical, Inc.
11828
In Commercial Distribution

  • 00810335020129 ()


  • Infusion pump programmer

NobelClinician® - 07332747125177

NobelClinician 3.1 for MAC
Nobel Biocare AB
3.1
Not in Commercial Distribution

  • 07332747125177 ()
101560

  • General-purpose dental x-ray system application software

NobelClinician® - 07332747125160

NobelClinician 3.1 for Windows 64-bit
Nobel Biocare AB
3.1
Not in Commercial Distribution

  • 07332747125160 ()
101560

  • General-purpose dental x-ray system application software

NobelClinician® - 07332747125153

NobelClinician 3.1 for Windows 32-bit
Nobel Biocare AB
3.1
Not in Commercial Distribution

  • 07332747125153 ()
101560

  • General-purpose dental x-ray system application software

NobelClinician® - 07332747124972

NobelClinician 2.8 for Windows MAC
Nobel Biocare AB
2.8
Not in Commercial Distribution

  • 07332747124972 ()
101560

  • General-purpose dental x-ray system application software

NobelClinician® - 07332747124958

NobelClinician 2.8 for Windows 64-bit
Nobel Biocare AB
2.8
Not in Commercial Distribution

  • 07332747124958 ()
101560

  • General-purpose dental x-ray system application software

NobelClinician® - 07332747124941

NobelClinician 2.8 for Windows 32-bit
Nobel Biocare AB
2.8
Not in Commercial Distribution

  • 07332747124941 ()
101560

  • General-purpose dental x-ray system application software

LungVision System - 07290017652085

The LungVision System is designed to enable users to segment previously acquired 3D CT data sets and overlay and register these 3D segmented data sets with live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures. The mobile system cart is an optional unit to place the LUNGVISIONTM Main Unit and router, also used for storing all the system components: LV Board, Tablet, DVD reader, Keyboard, Mouse and cables.
BODY VISION MEDICAL LTD
Core
In Commercial Distribution

  • 07290017652085 ()
LV1055002

  • Virtual bronchoscopic navigation PACS software

LungVision System - 07290017652030

The LungVision System is designed to enable users to segment previously acquired 3D CT data sets and overlay and register these 3D segmented data sets with live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures.
BODY VISION MEDICAL LTD
Core
In Commercial Distribution

  • 07290017652030 ()
LV1055001

  • Virtual bronchoscopic navigation PACS software
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