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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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Roche Molecular Systems, Inc.
09341862001
In Commercial Distribution

  • 07613336193242 ()
09341862001

  • Self-care monitoring/reporting software
Software as a Medical Device (SaMD) which operates as a medication reminder and support services; Operates on Android devices.
Astellas Pharma Us, Inc.
Android (Version 1)
In Commercial Distribution

  • 00304692416447 ()
DIGI-002

  • Medication reminder application software
Software as a Medical Device (SaMD) which operates as a medication reminder and support services; Operates on Apple iOS devices.
Astellas Pharma Us, Inc.
iOS (Version 1)
In Commercial Distribution

  • 00304692416089 ()
DIGI-001

  • Medication reminder application software
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers).
ELI LILLY AND COMPANY
MA9131 Android
In Commercial Distribution

  • 00300021109554 ()
MA9131001AM

  • Medication reminder application software
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices.
ELI LILLY AND COMPANY
MA7723 IOS
In Commercial Distribution

  • 00300021107550 ()
MA7723001AM

  • Medication reminder application software
BeCareLink MS is a mobile medical application designed to assist individuals diagnosed with Multiple Sclerosis (MS) in tracking, assessing, and managing their condition. The application allows users to complete periodic assessments that measure various neurological functions, including cognitive processing, motor coordination, and speech. These assessments are designed to provide longitudinal data regarding disease progression and symptom variability. The app stores user responses and performance data, which can be reviewed by healthcare professionals to aid in clinical decision-making. The software does not provide a diagnosis or treatment recommendation but functions as a patient management and monitoring tool.
BeCare Link, LLC
MS 2.1
In Commercial Distribution

  • 00199284085701 ()
BCL-MS

  • Self-care monitoring/reporting software
The HoloXR Health Connect is an adjunctive tool to facilitate telecollaboration and consultation to gain the ability of leverage specialized clinicians for collaborative care from any location during surgical and outpatient procedures through real-time transmission of visual and auditory information.
Holoray Inc.
1.0.0
In Commercial Distribution

  • G721HXR0 ()
HXR

  • Clinical training/education software
No Description
Sonova AG
n/a
In Commercial Distribution

  • 07613389779950 ()
058-5268-057

  • Audiometric/hearing device software
No Description
Sonova AG
n/a
In Commercial Distribution

  • 07613389736304 ()
058-5237-057

  • Audiometric/hearing device software
No Description
Sonova AG
n/a
In Commercial Distribution

  • 07613389736281 ()
058-5180-057

  • Audiometric/hearing device software
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