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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Widex ToneLink App iOS
Widex A/S
ToneLink app
In Commercial Distribution

  • 05706069702958 ()
5 300 0016 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Beyond App iOS 1.2
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069689105 ()
5 300 0008 001

  • Hearing aid/implant system remote control
Sirona B iOS App
DATRIX LLC
RX22674
In Commercial Distribution

  • 00851074007132 ()


  • Telemetric electrocardiographic ambulatory recorder
TempTraq Patient iOS App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006371 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Clinician iOS App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Clinician iOS App
Not in Commercial Distribution

  • 00851203006142 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Patient iOS App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Patient iOS App
Not in Commercial Distribution

  • 00851203006135 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Consumer iOS App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Consumer iOS App
Not in Commercial Distribution

  • 00851203006043 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
Widex MOMENT App iOS
Widex A/S
Moment app
In Commercial Distribution

  • 05706069930313 ()
5 300 0021 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
iCare PATIENT2 (iOS version)
ICARE FINLAND OY
TS05
In Commercial Distribution

  • 06430033851098 ()


  • Medical equipment clinical data interfacing software
Oticon RemoteCare 3.3.0 iOS
Sbo Hearing A/S
228209
In Commercial Distribution

  • 05714464012930 ()


  • Hearing aid/implant system remote control
RemoteLink Connect 3.3.0 iOS
Sbo Hearing A/S
228203
In Commercial Distribution

  • 05714464012879 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.5.0 IOS
Sbo Hearing A/S
228198
In Commercial Distribution

  • 05714464012824 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2.5.0 IOS
Sbo Hearing A/S
228196
In Commercial Distribution

  • 05714464012800 ()


  • Hearing aid/implant system remote control
OTICON ON 2.5.0 IOS
Sbo Hearing A/S
228193
In Commercial Distribution

  • 05714464012770 ()


  • Hearing aid/implant system remote control
OTICON ON 2.4.0 IOS
Sbo Hearing A/S
226657
In Commercial Distribution

  • 05714464012275 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2.4.0 IOS
Sbo Hearing A/S
226431
In Commercial Distribution

  • 05714464012084 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.4.0 IOS
Sbo Hearing A/S
226429
In Commercial Distribution

  • 05714464012060 ()


  • Hearing aid/implant system remote control
OTICON ON 2.3.0 IOS
Sbo Hearing A/S
224170
In Commercial Distribution

  • 05714464011612 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2.3.0 IOS
Sbo Hearing A/S
220593
In Commercial Distribution

  • 05714464011308 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.3.0 IOS
Sbo Hearing A/S
220591
In Commercial Distribution

  • 05714464011285 ()


  • Hearing aid/implant system remote control
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