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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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App for controlling Biomeme Frankin three9 thermocycler when used with the Biomeme Real-Time RT-PCR SARS-CoV-2 Test
Biomeme, Inc.
2.3.5
In Commercial Distribution

  • 00810096640130 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Eversense CGM Mobile Application (android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5502-01-300
Not in Commercial Distribution

  • 00817491023612 ()
FG-5502-01-300

  • Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-01-300
Not in Commercial Distribution

  • 00817491023605 ()
FG-5501-01-300

  • Implantable glucose monitoring system
The Eversense NOW Remote Monitoring App is intended for home use. The mobile app is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information. The secondary display is not a replacement for either real time continuous glucose monitoring using the Eversense CGM System’s primary display, or for home blood glucose monitoring. The Eversense NOW Remote Monitoring App is not intended to be used to make treatment decisions or therapy adjustments.
SENSEONICS, INCORPORATED
FG-5902-01-300
In Commercial Distribution

  • 00817491023490 ()
FG-5902-01-300

  • Implantable glucose monitoring system
Eversense CGM Mobile Application (android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5502-01-300
Not in Commercial Distribution

  • 00817491022387 ()
FG-5502-01-300

  • Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-01-300
Not in Commercial Distribution

  • 00817491022370 ()
FG-5501-01-300

  • Implantable glucose monitoring system
Eversense CGM Mobile Application (Android) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5600-01-300
Not in Commercial Distribution

  • 00817491020826 ()
FG-5600-01-300

  • Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5500-01-300
Not in Commercial Distribution

  • 00817491020819 ()
FG-5500-01-300

  • Implantable glucose monitoring system
No Description
Dexcom, Inc.
SW14131
In Commercial Distribution

  • 00386270004659 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
No Description
Dexcom, Inc.
SW14117
In Commercial Distribution

  • 00386270004642 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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