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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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PRC - 00816486021060

Quasselkiste App
PRENTKE ROMICH COMPANY
Quasselkiste App
In Commercial Distribution

  • 00816486021060 ()
19285-2

  • Voice synthesizer/digitizer

Sonova - 07613389310979

myPhonak app
Sonova AG
088-0011
In Commercial Distribution

  • 07613389310979 ()
088-0011

  • Audiometric/hearing device software

Phonak - 07613389082623

myPhonak (App)
Sonova AG
088-0008-03
In Commercial Distribution

  • 07613389082623 ()
088-0008-03

  • Audiometric/hearing device software

DreamMapper - 00606959047518

DreamMapper Mobile Application Android (APAC)
Respironics, Inc.
2.8
In Commercial Distribution

  • 00606959047518 ()
1127960

  • Self-care monitoring/reporting software

DreamMapper - 00606959046825

DreamMapper Mobile Application Android (EMEA)
Respironics, Inc.
2.7
In Commercial Distribution

  • 00606959046825 ()
1128265

  • Self-care monitoring/reporting software

DreamMapper - 00606959046795

DreamMapper Mobile Application Android (APAC)
Respironics, Inc.
2.7
In Commercial Distribution

  • 00606959046795 ()
1127960

  • Self-care monitoring/reporting software

DreamMapper - 00606959044418

DreamMapper Mobile Application Android (EMEA)
Respironics, Inc.
2.6
In Commercial Distribution

  • 00606959044418 ()
1128265

  • Self-care monitoring/reporting software

DreamMapper - 00606959044388

DreamMapper Mobile Application Android (APAC)
Respironics, Inc.
2.6
In Commercial Distribution

  • 00606959044388 ()
1127960

  • Self-care monitoring/reporting software

DreamMapper - 00606959041998

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

  • 00606959041998 ()
1127960

  • Self-care monitoring/reporting software

DreamMapper - 00606959047501

DreamMapper Mobile Application Android (EMEA)
Respironics, Inc.
2.8
In Commercial Distribution

  • 00606959047501 ()
1128265

  • Self-care monitoring/reporting software

Tandem t:slim Mobile Application, Android - 00389152470641

Tandem t:slim Mobile Application, Android
Tandem Diabetes Care, Inc.
1014706
In Commercial Distribution

  • 00389152470641 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

Philips - 05714464127160

PHILIPS HEARLINK 2 1.2.0 ANDROID
Sbo Hearing A/S
265707
In Commercial Distribution

  • 05714464127160 ()


  • Hearing aid/implant system remote control

Philips - 05714464125210

PHILIPS HEARLINK 2 1.1.0 ANDROID
Sbo Hearing A/S
264787
In Commercial Distribution

  • 05714464125210 ()


  • Hearing aid/implant system remote control

Philips - 05714464133970

PHILIPS HEARLINK 2 1.3.0 ANDROID
Sbo Hearing A/S
269357
In Commercial Distribution

  • 05714464133970 ()


  • Hearing aid/implant system remote control

Sonic - 05714464127184

SONIC SOUNDLINK 3 1.2.0 ANDROID
Sbo Hearing A/S
265709
In Commercial Distribution

  • 05714464127184 ()


  • Hearing aid/implant system remote control

Philips - 05714464034642

Philips HearLink Connect 3.4.0 Android
Sbo Hearing A/S
234031
In Commercial Distribution

  • 05714464034642 ()


  • Hearing aid/implant system remote control

Sonic - 05714464034628

Sonic SoundLink Connect 3.4.0 Android
Sbo Hearing A/S
234029
In Commercial Distribution

  • 05714464034628 ()


  • Hearing aid/implant system remote control

Bernafon - 05714464034604

Bernafon EasyControl Connect 3.4.0 Android
Sbo Hearing A/S
234027
In Commercial Distribution

  • 05714464034604 ()


  • Hearing aid/implant system remote control

Philips - 05714464012947

Philips HearLink Connect 3.3.0 Android
Sbo Hearing A/S
228210
In Commercial Distribution

  • 05714464012947 ()


  • Hearing aid/implant system remote control

Philips - 05714464004614

PHILIPS HEARLINK CONNECT 3.1.0 ANDROID
Sbo Hearing A/S
215185
In Commercial Distribution

  • 05714464004614 ()


  • Hearing aid/implant system remote control
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