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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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Cognition Chronicle v2.1 - 00860007318764

No Description
Qr8 Health Inc
CHR-COG-21
In Commercial Distribution

  • 00860007318764 ()


  • Cognitive assessment software

Cognition Snapshot+ 2.1.0 - 00860007318740

No Description
Qr8 Health Inc
SNP-GOG-21
Not in Commercial Distribution

  • 00860007318740 ()


  • Cognitive assessment software

Cognition Chronicle - 00860007318733

No Description
Qr8 Health Inc
CHR-COG-10
Not in Commercial Distribution

  • 00860007318733 ()


  • Cognitive assessment software

Chronicle Web - 00860007318726

No Description
Qr8 Health Inc
CHR-COG-W10
Not in Commercial Distribution

  • 00860007318726 ()


  • Cognitive assessment software

Cognition Snapshot v2.0 - 00860007318719

No Description
Qr8 Health Inc
SNP-COG-20
Not in Commercial Distribution

  • 00860007318719 ()


  • Cognitive assessment software

CommonPath Enterprise - 00860006582005

Critical Alert CommonPath Enterprise (CommonPath) is a software application installed on a Windows server environment capable of acquiring alarms, events, and parameters from clinical systems and intelligently forwarding this information as notifications to designated display devices provided by third-party mobile device companies.
Critical Alert
In Commercial Distribution

  • 00860006582005 ()


  • Alarm application software

proudP - 00860006184926

proudP is a mobile application intended for measuring voided volume of urine and urine flow rate using the sound recorded by microphone in mobile devices. This device can be used for assessment of voiding function. This device can be used at office and required to be used in a quiet environment. This device targets patients over 18 years of age.
Soundable Health, Inc.
SU-UFM-001
In Commercial Distribution

  • 00860006184926 ()


  • Home uroflowmetry software

Oncospace - 00860004284901

No Description
Oncospace, Inc.
System
In Commercial Distribution

  • 00860004284901 ()


  • Radiation therapy software

myVisionTrack - 00860003376157

Vision testing application - iOS version
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376157 ()


  • Vision self-testing software

myVisionTrack - 00860003376119

Vision testing application - HCP Portal
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376119 ()


  • Vision self-testing software
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