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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 - 00606959059795

DreamMapper Mobile iOS APAC Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059795 ()
1127959

  • Self-care monitoring/reporting software

DreamMapper - 00606959059788

DreamMapper Mobile iOS EU Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059788 ()
1128264

  • Self-care monitoring/reporting software

DreamMapper - 00606959059771

DreamMapper Mobile iOS NA Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059771 ()
1101478

  • Self-care monitoring/reporting software

DreamMapper - 00606959059078

DreamMapper iOS China Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059078 ()
1136968

  • Self-care monitoring/reporting software

DreamMapper - 00606959059061

DreamMapper iOS APAC Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059061 ()
1127959

  • Self-care monitoring/reporting software

DreamMapper - 00606959059054

DreamMapper iOS EU Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059054 ()
1128264

  • Self-care monitoring/reporting software

DreamMapper - 00606959059047

DreamMapper iOS NA Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059047 ()
1101478

  • Self-care monitoring/reporting software

DreamMapper - 00606959057210

DreamMapper iOS China Instance v 2.20
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959057210 ()
1136968

  • Self-care monitoring/reporting software

DreamMapper - 00606959057203

DreamMapper iOS APAC Instance v 2.20
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959057203 ()
1127959

  • Self-care monitoring/reporting software

DreamMapper - 00606959057197

DreamMapper iOS EU Instance v 2.20
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959057197 ()
1128264

  • Self-care monitoring/reporting software

DreamMapper - 00606959057180

DreamMapper iOS NA Instance v 2.20
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959057180 ()
1101478

  • Self-care monitoring/reporting software

Hearing Test Feature (HTF) - 00195949149948

Hearing Test Feature iOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149948 ()


  • Self-testing tone audiometer

Hearing Aid Feature (HAF) - 00195949149924

Hearing Aid Feature iOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149924 ()


  • Air-conduction hearing aid, in-the-ear

Reveal LINQ™ Mobile Manager - 00643169636651

SW MSW002 LINQ PROGRAMMER iOS APP
MEDTRONIC, INC.
MSW002
In Commercial Distribution

  • 00643169636651 ()


  • Implantable cardiac device management application software

Baha - 09321502036382

Cochlear Baha Control App for iOS
Cochlear Bone Anchored Solutions AB
95459
In Commercial Distribution

  • 09321502036382 ()
95459

  • Hearing aid/implant system remote control

DreamMapper - 00606959054295

DreamMapper iOS, China Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054295 ()
1136968

  • Self-care monitoring/reporting software

DreamMapper iOS China Instance - 00606959051362

DreamMapper iOS China Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051362 ()
1136968

  • Self-care monitoring/reporting software

DreamMapper App iOS (APAC) - 00606959051355

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

  • 00606959051355 ()
1127959

  • Self-care monitoring/reporting software

DreamMapper App iOS (EMEA) - 00606959051348

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

  • 00606959051348 ()
1128264

  • Self-care monitoring/reporting software

DreamMapper App iOS - 00606959051331

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

  • 00606959051331 ()
1101478

  • Self-care monitoring/reporting software

DreamMapper iOS China Instance v 2.11 - 00606959049963

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

  • 00606959049963 ()
1136968

  • Self-care monitoring/reporting software

DreamMapper App iOS (APAC) - 00606959049956

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

  • 00606959049956 ()
1127959

  • Self-care monitoring/reporting software

DreamMapper App iOS (EMEA) - 00606959049949

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

  • 00606959049949 ()
1128264

  • Self-care monitoring/reporting software

DreamMapper App iOS - 00606959049932

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

  • 00606959049932 ()
1101478

  • Self-care monitoring/reporting software

DreamMapper App iOS (APAC) - 00606959049109

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

  • 00606959049109 ()
1127959

  • Self-care monitoring/reporting software

DreamMapper App iOS (EMEA) - 00606959049093

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

  • 00606959049093 ()
1128264

  • Self-care monitoring/reporting software

DreamMapper App iOS - 00606959049086

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

  • 00606959049086 ()
1101478

  • Self-care monitoring/reporting software

GN ReSound - 05708296071517

APP,RS SMART 3D,1.0,IOS
Gn Hearing A/S
20410600
In Commercial Distribution

  • 05708296071517 ()


  • Hearing aid/implant system remote control

Beltone - 05708296071494

APP,BT SMART REMOTE,1.0.6,IOS
Gn Hearing A/S
20409600
In Commercial Distribution

  • 05708296071494 ()


  • Hearing aid/implant system remote control

GN ReSound - 05708296071456

APP,KIRKL SIGN NAV,1.0.6,IOS
Gn Hearing A/S
20409700
In Commercial Distribution

  • 05708296071456 ()


  • Hearing aid/implant system remote control

Athena GTX Device Management Suite (ADMS) Software - B3943950009000

Athena GTX Device Management Suite - iOS
ATHENA GTX, INC.
ADMS iOS Software
In Commercial Distribution

  • B3943950009000 ()
395-0009-00

  • Centralized patient monitor

TRUE MANAGER AIR - 00021292013196

TRUE MANAGER AIR APP - Apple iOS
TRIVIDIA HEALTH, INC.
TRUE MANAGER AIR APP - Apple iOS
In Commercial Distribution

  • 00021292013196 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000943264

SFTWR MMT-6102 AHCL APP 2.6 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000943264 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000910150

SFTWR MMT-6102 AHCL APP 2.5 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000910150 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000968175

SFTWR MMT-6102 AHCL APP 2.7 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000968175 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000867638

SFTWR MMT-6102 AHCL APP 2.2 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000867638 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000827793

Sftwr MMT-6102 AHCL 2.1.1 App iOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000827793 ()


  • Self-care monitoring/reporting software

CareLink™ Connect - 00763000827304

Sftwr MMT-6112 CP iOS 3.3.1 US
MEDTRONIC MINIMED, INC.
MMT-6112
In Commercial Distribution

  • 00763000827304 ()


  • Patient health record information system application software

CareLink™ Connect - 00763000437787

SFTWR MMT-6112 CP IOS V2.3.0 US
MEDTRONIC MINIMED, INC.
MMT-6112
In Commercial Distribution

  • 00763000437787 ()


  • Patient health record information system application software

CareLink ™Connect - 00763000432645

SFTWR MMT-6112 CP IOS V2.2.0 OUS
MEDTRONIC MINIMED, INC.
MMT-6112
In Commercial Distribution

  • 00763000432645 ()


  • Patient health record information system application software
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