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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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Sonova Brand - 07613389475173

myPhonak Junior app
Sonova AG
088-0017-21
In Commercial Distribution

  • 07613389475173 ()
088-0017-21

  • Audiometric/hearing device software

Unitron - 07613389444391

HelloGo Hearing App
Unitron Hearing Division
088-5012
In Commercial Distribution

  • 07613389444391 ()
088-5012

  • Audiometric/hearing device software

Sonova Brand - 07613389430639

myPhonak 5.0 app
Sonova AG
088-0014
In Commercial Distribution

  • 07613389430639 ()
088-0014

  • Audiometric/hearing device software

Sonova Brand - 07613389430622

myPhonak 5.0 app
Sonova AG
088-0014-71
In Commercial Distribution

  • 07613389430622 ()
088-0014-71

  • Audiometric/hearing device software

Sonova Brand - 07613389430615

myPhonak 5.0 app
Sonova AG
088-0014-83
In Commercial Distribution

  • 07613389430615 ()
088-0014-83

  • Audiometric/hearing device software

Sonova Brand - 07613389430608

myPhonak 5.0 app
Sonova AG
088-0014-22
In Commercial Distribution

  • 07613389430608 ()
088-0014-22

  • Audiometric/hearing device software

Sonova Brand - 07613389430592

myPhonak 5.0 app
Sonova AG
088-0014-09
In Commercial Distribution

  • 07613389430592 ()
088-0014-09

  • Audiometric/hearing device software

Sonova Brand - 07613389430585

myPhonak 5.0 app
Sonova AG
088-0014-06
In Commercial Distribution

  • 07613389430585 ()
088-0014-06

  • Audiometric/hearing device software

Sonova Brand - 07613389430578

myPhonak 5.0 app
Sonova AG
088-0014-14
In Commercial Distribution

  • 07613389430578 ()
088-0014-14

  • Audiometric/hearing device software

Sonova Brand - 07613389430561

myPhonak 5.0 app
Sonova AG
088-0014-46
In Commercial Distribution

  • 07613389430561 ()
088-0014-46

  • Audiometric/hearing device software

Sonova Brand - 07613389430554

myPhonak 5.0 app
Sonova AG
088-0014-26
In Commercial Distribution

  • 07613389430554 ()
088-0014-26

  • Audiometric/hearing device software

Sonova Brand - 07613389430547

myPhonak 5.0 app
Sonova AG
088-0014-28
In Commercial Distribution

  • 07613389430547 ()
088-0014-28

  • Audiometric/hearing device software

Sonova Brand - 07613389430530

myPhonak 5.0 app
Sonova AG
088-0014-12
In Commercial Distribution

  • 07613389430530 ()
088-0014-12

  • Audiometric/hearing device software

Sonova Brand - 07613389430523

myPhonak 5.0 app
Sonova AG
088-0014-16
In Commercial Distribution

  • 07613389430523 ()
088-0014-16

  • Audiometric/hearing device software

Sonova Brand - 07613389430509

myPhonak 5.0 app
Sonova AG
088-0014-92
In Commercial Distribution

  • 07613389430509 ()
088-0014-92

  • Audiometric/hearing device software

Sonova Brand - 07613389430493

myPhonak 5.0 app
Sonova AG
088-0014-19
In Commercial Distribution

  • 07613389430493 ()
088-0014-19

  • Audiometric/hearing device software

Sonova Brand - 07613389430479

myPhonak 5.0 app
Sonova AG
088-0014-25
In Commercial Distribution

  • 07613389430479 ()
088-0014-25

  • Audiometric/hearing device software

Sonova Brand - 07613389430462

myPhonak 5.0 app
Sonova AG
088-0014-97
In Commercial Distribution

  • 07613389430462 ()
088-0014-97

  • Audiometric/hearing device software

Phonak Brand - 07613389403190

myPhonak 4.0 app
Sonova AG
088-0013-71
In Commercial Distribution

  • 07613389403190 ()
088-0013-71

  • Audiometric/hearing device software

Phonak Brand - 07613389403183

myPhonak 4.0 app
Sonova AG
088-0013-83
In Commercial Distribution

  • 07613389403183 ()
088-0013-83

  • Audiometric/hearing device software

Phonak Brand - 07613389403176

myPhonak 4.0 app
Sonova AG
088-0013-22
In Commercial Distribution

  • 07613389403176 ()
088-0013-22

  • Audiometric/hearing device software

Phonak Brand - 07613389403169

myPhonak 4.0 app
Sonova AG
088-0013-09
In Commercial Distribution

  • 07613389403169 ()
088-0013-09

  • Audiometric/hearing device software

Phonak Brand - 07613389403152

myPhonak 4.0 app
Sonova AG
088-0013-06
In Commercial Distribution

  • 07613389403152 ()
088-0013-06

  • Audiometric/hearing device software

Phonak Brand - 07613389403145

myPhonak 4.0 app
Sonova AG
088-0013-14
In Commercial Distribution

  • 07613389403145 ()
088-0013-14

  • Audiometric/hearing device software

Phonak Brand - 07613389399301

myPhonak 4.0 app
Sonova AG
088-0013-18
In Commercial Distribution

  • 07613389399301 ()
088-0013-18

  • Audiometric/hearing device software

Phonak Brand - 07613389399295

myPhonak 4.0 app
Sonova AG
088-0013-70
In Commercial Distribution

  • 07613389399295 ()
088-0013-70

  • Audiometric/hearing device software

Phonak Brand - 07613389399288

myPhonak 4.0 app
Sonova AG
088-0013-24
In Commercial Distribution

  • 07613389399288 ()
088-0013-24

  • Audiometric/hearing device software

Phonak Brand - 07613389399271

myPhonak 4.0 app
Sonova AG
088-0013-21
In Commercial Distribution

  • 07613389399271 ()
088-0013-21

  • Audiometric/hearing device software

UbiqVue - B353UA2251R1

Holter Mobile App
Lifesignals, Inc.
UA2251-R
In Commercial Distribution

  • B353UA2251R1 ()


  • Medical equipment clinical data interfacing software

Eloquence - 00816486021237

Eloquence iOS App
PRENTKE ROMICH COMPANY
Eloquence App
In Commercial Distribution

  • 00816486021237 ()
19683

  • Voice synthesizer/digitizer

PRC-Saltillo - 00816486021183

Dialogue AAC App
PRENTKE ROMICH COMPANY
Dialogue App
In Commercial Distribution

  • 00816486021183 ()
18312

  • Voice synthesizer/digitizer

Saltillo - 00816486021053

TouchChat HD App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021053 ()
18626-4

  • Voice synthesizer/digitizer

Saltillo - 00816486021022

Classic TouchChat App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021022 ()
18626-0

  • Voice synthesizer/digitizer

Nalu Medical, Inc. - 00812537030463

SCS Programming App
NALU MEDICAL, INC.
53001
In Commercial Distribution

  • 00812537030463 ()
53001

  • Implantable electrical stimulation device management software

DreamMapper - 00606959057692

DreamMapper App iOS
Respironics, Inc.
DreamMapper iOS, North American Instance - 2
In Commercial Distribution

  • 00606959057692 ()
1101478

  • Self-care monitoring/reporting software

Dexcom G7 Android App - 00386270001870

G7 Android App
Dexcom, Inc.
SW12299
In Commercial Distribution

  • 00386270001870 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Dexcom G7 iOS App - 00386270001863

G7 iOS App
Dexcom, Inc.
SW12300
In Commercial Distribution

  • 00386270001863 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

mySCS™ GO - 00191506020705

Therapy Controller App
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-5275
In Commercial Distribution

  • 00191506020705 ()


  • Implantable spinal cord electrical stimulation system programmer

My Dose Coach - 04030685900018

Insulin Titration App
Sanofi-Aventis Deutschland GmbH
2.x.x
Not in Commercial Distribution


  • No size - Software as a Medical Device
N/A

  • Clinical management support software

Arial - 00840948100963

Arial Mobile App
Securitas Healthcare LLC
54600
In Commercial Distribution

  • 00840948100963 ()


  • Alarm application software
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