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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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DreamMapper Mobile App Android (DMM) - 00606959049895

DreamMapper Android NA Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049895 ()
1101479

  • Self-care monitoring/reporting software

DreamMapper Mobile App Android (DMM) - 00606959049055

DreamMapper Android NA Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution

  • 00606959049055 ()
1101479

  • Self-care monitoring/reporting software

Dexcom Stelo iOS Watch App - 00386270004659

No Description
Dexcom, Inc.
SW14131
In Commercial Distribution

  • 00386270004659 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Dexcom Stelo Android Mobile App - 00386270004642

No Description
Dexcom, Inc.
SW14117
In Commercial Distribution

  • 00386270004642 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Dexcom Stelo iOS Mobile App - 00386270004635

No Description
Dexcom, Inc.
SW14116
In Commercial Distribution

  • 00386270004635 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

DreamMapper Mobile App Android (EMEA) - 00606959042025

DreamMapper Mobile Application Android (EMEA)
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959042025 ()
1128265

  • Self-care monitoring/reporting software

Eko Mobile App Android International - 00850010298061

Eko mobile app for android international platforms for use with Eko medical devices.
Eko Devices, Inc.
com.ekodevices.android.intl
In Commercial Distribution

  • 00850010298061 ()


  • Medical equipment clinical data interfacing software

GENESIS BI-WING APP GEN 3.0 - 00860003986806

No Description
Infinitus Medical Technologies LLC
FPLS-3000
In Commercial Distribution

  • 00860003986806 ()
FPLS-3000

  • Operating table patient positioning set, single-use

Eversense® Mobile App Android - 00817491023612

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® Mobile App iOS - 00817491023605

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
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