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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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COMPASS GPS 3.3 package (English)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069858471 ()
7 503 0135 001

  • Audiometric/hearing device software
COMPASS GPS 3.4 DVD package (Spanish)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069887839 ()
7 503 0137 004

  • Audiometric/hearing device software
COMPASS GPS 3.4 DVD package (German)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069887815 ()
7 503 0137 002

  • Audiometric/hearing device software
COMPASS GPS 3.4 DVD package (English)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069887808 ()
7 503 0137 001

  • Audiometric/hearing device software
Optum Home Scale I-ICUE
OPTUMHEALTH CARE SOLUTIONS, INC.
EM724BT
Not in Commercial Distribution

  • 00862492000322 ()
AAA-85009

  • Self-care monitoring/reporting software
Optum Home Scale I-Apollo
OPTUMHEALTH CARE SOLUTIONS, INC.
EM724BT
Not in Commercial Distribution

  • 00862492000315 ()
AAA-80012

  • Self-care monitoring/reporting software
The Telserve® Data Management System is an accessory to blood glucose monitoring systems for the review and evaluation of blood glucose test results to aid in diabetes management.
TELCARE, LLC
DMS
In Commercial Distribution

  • 00859519002247 ()


  • Self-care monitoring/reporting software
ACC SOUNDCONNECT LANG PACK_1
Widex A/S
ACC SOUNDCONNECT LANG PACK_1
In Commercial Distribution

  • 05714880213270 ()
8 928 0100 000

  • Audiometric/hearing device software
No Description
Phillips-Medisize A/S
Android (Mobile App)
Not in Commercial Distribution

  • 05713495000060 ()
84601063

  • Medication reminder application software
No Description
Phillips-Medisize A/S
iOS (Mobile App)
Not in Commercial Distribution

  • 05713495000053 ()
84601063

  • Medication reminder application software
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