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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 - 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 - 05706069666113

COMPASS GPS V2.4 VA package (English)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069666113 ()
7 503 0118 001

  • Audiometric/hearing device software

Coselgi - 05706069666083

Coselgi C-tune II V2.4 DVD
Widex A/S
C-Tune II
In Commercial Distribution

  • 05706069666083 ()
9 513 0202 000

  • Audiometric/hearing device software

Widex - 05706069665819

COMPASS GPS V2.4, USB plug
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069665819 ()
9 503 0855 000

  • Audiometric/hearing device software

Widex - 05706069665796

COMPASS GPS V2.4 package (Spanish)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069665796 ()
7 503 0117 004

  • Audiometric/hearing device software

Widex - 05706069665789

COMPASS GPS V2.4 package (French)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069665789 ()
7 503 0117 003

  • Audiometric/hearing device software

Widex - 05706069665772

COMPASS GPS V2.4 package (German)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069665772 ()
7 503 0117 002

  • Audiometric/hearing device software

Widex - 05706069665765

COMPASS GPS V2.4 package (English)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069665765 ()
7 503 0117 001

  • Audiometric/hearing device software

Sanitas™ Clinical Care Platform - 00860508000311

The Sanitas™ Clinical Care Platform is a software system that collects patient physiological data (such as blood pressure and blood sugar levels) for transmission to a secure central storage server, which can be accessed by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. These data are also available to the patient for viewing purposes and as an aid in maintaining wellness regiments. The Sanitas™ Clinical Care Platform is an accessory software application that is used by patients in non-clinical settings (e.g. home), to collect, record and transmit their physiological information to a remote secure server. Stored data is accessible by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. The Sanitas Clinical Care Platform is also intended to be used in combination with a variety of external vital sign devices. The Sanitas Clinical Care Platform does not measure, interpret or make any decisions on the data that it conveys. It is not intended as a replacement for the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring.
SANITAS, INC.
Version 3.0 Released 20160615
Not in Commercial Distribution

  • 00860508000311 ()


  • Self-care monitoring/reporting software
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