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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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
Sirona B iOS App
DATRIX LLC
RX22674
In Commercial Distribution

  • 00851074007132 ()


  • Telemetric electrocardiographic ambulatory recorder
Widex MOMENT App iOS
Widex A/S
Moment app
In Commercial Distribution

  • 05706069930313 ()
5 300 0021 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
IOS Remote Control App
INTRICON CORPORATION
Remote
In Commercial Distribution

  • 00858177007069 ()
22957

  • Audiometric/hearing device software
ON APP 1.2 IOS
Oticon A/S
176634
In Commercial Distribution

  • 05707131328519 ()


  • Hearing aid/implant system remote control
MYAIR FOR IOS APP
RESMED CORP.
22245
In Commercial Distribution

  • 00840193400115 ()
22245

  • Self-care monitoring/reporting software
CIONIC iOS Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000030 ()
62000003

  • Gait-enhancement electrical stimulation system, external
Libre IOS App US
ABBOTT DIABETES CARE INC
78746-01
In Commercial Distribution

  • 00357599841003 ()
78746-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Biim iOS App, P2.0
Biim Ultrasound AS
P001424
In Commercial Distribution

  • 07090045490327 ()
P001424

  • Hand-held ultrasound imaging system, body-surface
  • Extracorporeal ultrasound imaging transducer, hand-held
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