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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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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

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

Veris Health - 00860009591004

Medical Device Data Systems (MDDS)
Veris Health Inc.
Veris Health Platform
In Commercial Distribution

  • 00860009591004 ()


  • Self-care monitoring/reporting software

OculoMotor Technologies - 00860012940608

Virtual Eye Rotation Vision Exercises for Convergence Insufficiency Therapy
Oculomotor Technologies Inc.
VERVE
In Commercial Distribution

  • 00860012940608 ()


  • Virtual-display routine exercise software

Oracle Health Patient Observer - 00853023006241

No Description
Cerner Corporation
CPO-I415
In Commercial Distribution

  • 00853023006241 ()
CFG_PATOBSRVR

  • Inpatient motion surveillance software

Oracle Health Patient Observer - 00853023006234

No Description
Cerner Corporation
CPO-SP6
In Commercial Distribution

  • 00853023006234 ()
CFG_PATOBSRVR

  • Inpatient motion surveillance software

Oracle Health Patient Observer - 00853023006203

No Description
Cerner Corporation
CPO-SP4
In Commercial Distribution

  • 00853023006203 ()
CFG_PATOBSRVR

  • Inpatient motion surveillance software

Oracle Patient Observer - 00853023006197

No Description
Cerner Corporation
CPO-SP
In Commercial Distribution

  • 00853023006197 ()
CFG_PATOBSRVR

  • Inpatient motion surveillance software

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
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