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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 Web China Instance v 2.11 - 00606959049888

DreamMapper Web China Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049888 ()
1136946

  • Self-care monitoring/reporting software

DreamMapper Web (APAC) - 00606959049871

DreamMapper Web APAC Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049871 ()
1127937

  • Self-care monitoring/reporting software

DreamMapper Web (EMEA) - 00606959049864

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

  • 00606959049864 ()
1128262

  • Self-care monitoring/reporting software

DreamMapper Web (DM) - 00606959049857

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

  • 00606959049857 ()
1101679

  • Self-care monitoring/reporting software

AudioKey 1.0 - 09008737097493

Mobile Application Remote Control
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
09749
Not in Commercial Distribution

  • 09008737097493 ()


  • Audiometric/hearing device software

AudioKey 2.0 - 09008737379353

Mobile Application Remote Control
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
37935
In Commercial Distribution

  • 09008737379353 ()


  • Audiometric/hearing device software

Xltek - 00382830043533

Sandman Elite 9.3 Install CD ENU
Embla Systems Ltd
4283000
In Commercial Distribution

  • 00382830043533 ()


  • Sleep disorder interpretive software

Xltek - 00382830043489

Enterprise 5.2 Installation CD
Embla Systems Ltd
1249014
In Commercial Distribution

  • 00382830043489 ()


  • Sleep disorder interpretive software

Xltek - 00382830043441

RemLogic 3.3.2 Installation CD ENU
Embla Systems Ltd
012001
In Commercial Distribution

  • 00382830043441 ()


  • Sleep disorder interpretive software
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