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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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Neuroventis Platform - 05419980275011

No Description
Neuroventis
2.x.x
In Commercial Distribution

  • 05419980275011 ()


  • Medication reminder application software

Neuroventis Platform - 05419980275004

No Description
Neuroventis
1.x.x
Not in Commercial Distribution

  • 05419980275004 ()


  • Medication reminder application software

Coselgi - 05706069510010

Coselgi C-Tune 2.0
Widex A/S
C-Tune
In Commercial Distribution

  • 05706069510010 ()
9 513 0102 000

  • Audiometric/hearing device software

Telserve® Data Management System - 00859519002247

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

myBETAapp - 05713495000060

No Description
Phillips-Medisize A/S
Android (Mobile App)
Not in Commercial Distribution

  • 05713495000060 ()
84601063

  • Medication reminder application software

myBETAapp - 05713495000053

No Description
Phillips-Medisize A/S
iOS (Mobile App)
Not in Commercial Distribution

  • 05713495000053 ()
84601063

  • Medication reminder application software

myBETAapp - 05713495000046

No Description
Phillips-Medisize A/S
Mac Thin Client (Desktop)
Not in Commercial Distribution

  • 05713495000046 ()
84601063

  • Medication reminder application software

myBETAapp - 05713495000039

No Description
Phillips-Medisize A/S
Windows Thin Client (Desktop)
Not in Commercial Distribution

  • 05713495000039 ()
84601063

  • Medication reminder application software

Teton Fall Detection - 05745001037000

Teton's Fall Detection system uses a device equipped with a camera to monitor the room, analyzing live video feeds through AI models that are processed locally. These models interpret human activity within the camera’s field of view and make real-time predictions, specifically detecting falls. At night, infrared lighting is used to enhance visibility, ensuring continuous monitoring. Once a fall is detected, the processed data is securely transmitted to care staff through a dedicated server, enabling timely intervention. The focus of this feature is precision and reliability, ensuring patient safety while minimizing system complexity by concentrating solely on fall detection rather than the broader ecosystem of the Teton One system.
Teton.AI ApS
R1.0
In Commercial Distribution

  • 05745001037000 ()


  • Inpatient motion surveillance software

Portal 724 - 00862492000322

Optum Home Scale I-ICUE
OPTUMHEALTH CARE SOLUTIONS, INC.
EM724BT
Not in Commercial Distribution

  • 00862492000322 ()
AAA-85009

  • Self-care monitoring/reporting software
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