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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 (APAC) - 00606959049079

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

  • 00606959049079 ()
1127960

  • 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

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

DreamMapper Mobile App Android (APAC) - 00606959051317

DreamMapper Android APAC Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051317 ()
1127960

  • Self-care monitoring/reporting software

DreamMapper Mobile App Android (EMEA) - 00606959051300

DreamMapper Android EU Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051300 ()
1128265

  • Self-care monitoring/reporting software

DreamMapper Mobile App Android (DMM) - 00606959051294

DreamMapper Android NA Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051294 ()
1101479

  • Self-care monitoring/reporting software

DreamMapper Mobile App Android (EMEA) - 00606959049901

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

  • 00606959049901 ()
1128265

  • Self-care monitoring/reporting software

DreamMapper Mobile App Android (EMEA) - 00606959049062

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

  • 00606959049062 ()
1128265

  • Self-care monitoring/reporting 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

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

Biomeme GoDx App for US - 00810096640130

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)

Medtronic Diabetes Updater app iOS - 00763000532178

SFTWR MMT-6122 FOTA IOS V1.3.4
MEDTRONIC MINIMED, INC.
MMT-6122
In Commercial Distribution

  • 00763000532178 ()


  • Patient health record information system application software

Medtronic Diabetes Updater app Android - 00763000532161

SFTWR MMT-6121 FOTA ANDROID V1.3.4
MEDTRONIC MINIMED, INC.
MMT-6121
In Commercial Distribution

  • 00763000532161 ()


  • Patient health record information system application 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

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

Eversense NOW Mobile App Android - 00817491023490

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® Mobile App Android - 00817491022387

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
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