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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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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
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
A pulse generator system for the treatment of cardiac dysrhythmias; re-manufactured, (unpackaged).
CARDIOCOMMAND, INC.
2A re-man'd, unpackaged
In Commercial Distribution

  • 00856233005158 ()
8002A-9999

  • External pacemaker, transoesophageal pacing
A pulse generator system for the treatment of cardiac dysrhythmias, (unpackaged unit).
CARDIOCOMMAND, INC.
2A, unpackaged
In Commercial Distribution

  • 00856233005066 ()
8002A

  • External pacemaker, transoesophageal pacing
Tubal Occluding Device in a sterile pouch (2 Hulka Clips per pouch)
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
4986.90
Not in Commercial Distribution

  • 00861523000102 ()
  • 10861523000109 ()
4986.09

  • Fallopian tube clip/band
A portable case that holds the Monitor while wearing the ASSURE system
Kestra Medical Technologies, Inc.
3326502-003
In Commercial Distribution

  • 00840241600207 ()
3326502-003

  • Wearable defibrillation system defibrillator
Eversense E3 Pouch contains one Eversense E3 Sensor in a Sensor holder.
SENSEONICS, INCORPORATED
102095-81A
In Commercial Distribution

  • 00817491023063 ()


  • Implantable glucose monitoring system sensor
Blood glucose test strips. Sold in a carton of 15 test strips.
ASCENSIA DIABETES CARE US INC.
7550
In Commercial Distribution

  • 40301937550155 ()
  • 00301937550157 ()
  • 10301937550154 ()
  • 00301937550065 ()
90001174

  • Glucose monitoring system IVD, home-use
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