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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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WIDEX - 05706069779714

APP WIDEX REMOTE CARE ANDROID
Widex A/S
Remote Care 1.3.4
In Commercial Distribution

  • 05706069779714 ()
21035228

  • Hearing aid/implant system remote control

WIDEX - 05706069779707

APP WIDEX REMOTE CARE IOS
Widex A/S
Remote Care 1.3.4
In Commercial Distribution

  • 05706069779707 ()
21035227

  • Hearing aid/implant system remote control

Cell Therapy 360 Wearable Tech V1 - 00851203006272

BMS CT360 Clinician Web App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Clinician Web App
Not in Commercial Distribution

  • 00851203006272 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

Cell Therapy 360 Wearable Tech V1 - 00851203006265

BMS CT360 Andriod Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Andriod Clinician App
Not in Commercial Distribution

  • 00851203006265 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

Cell Therapy 360 Wearable Tech V1 - 00851203006258

BMS CT360 iOS Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Clinician App
Not in Commercial Distribution

  • 00851203006258 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

Cell Therapy 360 Wearable Tech V1 - 00851203006241

BMS CT360 iOS Patient App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Patient App
Not in Commercial Distribution

  • 00851203006241 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

Cell Therapy 360 Wearable Tech V1 - 00851203006234

BMS CT360 Android Patient App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Android Patient App
Not in Commercial Distribution

  • 00851203006234 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

Widex - 05706069674729

Tinnitus app Android version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution

  • 05706069674729 ()
5 300 0007 001

  • Tinnitus masking application software

Widex - 05706069674712

Tinnitus app iOS version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution

  • 05706069674712 ()
5 300 0006 001

  • Tinnitus masking application software

Widex - 05706069673579

BEYOND app Android version 1.1
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069673579 ()
5 300 0005 001

  • Hearing aid/implant system remote control
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