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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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ASSURE Assist Service - 00840241600344

The Event Response System (ERS) is a software-only powered communication system that informs a remote user responder of the occurrence of a triggering event.
Kestra Medical Technologies, Inc.
80739-001
In Commercial Distribution

  • 00840241600344 ()
80739-001

  • Medical equipment clinical data interfacing software

CareStation Server - 00840241600306

CareStation Server acquires and displays data from the WCD for clinicians to view.
Kestra Medical Technologies, Inc.
80605-004
In Commercial Distribution

80605-004

  • Medical equipment clinical data interfacing software

CareStation Server - 00840241600290

CareStation Server acquires and displays data from the WCD for clinicians to view.
Kestra Medical Technologies, Inc.
80605-003
Not in Commercial Distribution

80605-003

  • Medical equipment clinical data interfacing software

ASSURE Patient Application - 00840241600283

ASSURE patient app is a component of CareStation.
Kestra Medical Technologies, Inc.
80601-001
In Commercial Distribution

80601-001

  • Medical equipment clinical data interfacing software

CareStation Server - 00840241600276

CareStation Server acquires and displays data from the WCD for clinicians to view.
Kestra Medical Technologies, Inc.
80433-003
Not in Commercial Distribution

80433-003

  • Medical equipment clinical data interfacing software

CareStation Server - 00840241600269

CareStation Server acquires and displays data from the WCD for clinicians to view.
Kestra Medical Technologies, Inc.
80433-002
Not in Commercial Distribution

  • 00840241600269 ()
80433-002

  • Medical equipment clinical data interfacing software

ASSURE Patient Application - 00840241600252

ASSURE patient app is a component of CareStation.
Kestra Medical Technologies, Inc.
80429-003
In Commercial Distribution

80429-003

  • Medical equipment clinical data interfacing software

ASSURE Patient Application - 00840241600214

ASSURE patient app is a component of the ASSURE WCD System and transmits information to CareStation
Kestra Medical Technologies, Inc.
80315-005
In Commercial Distribution

  • 00840241600214 ()
80315-005

  • Medical equipment clinical data interfacing software

APIWEB™ - 03573026133542

APIWEB is a web based application for interpretation of biochemical/digital profiles for identification of microorganisms obtained from ID 32, rapid ID 32, and API strips.
BIOMERIEUX SA
1.4
In Commercial Distribution

  • 03573026133542 ()


  • Human infectome analysis interpretive software IVD

myrecovery, myrecovery App & Dashboard, myrecovery Patient Engagement & Outcomes - G333OUG001

A clinical information and medical device data system for patient engagement and monitoring of treatment outcomes that can be customised by healthcare professionals to match their treatment pathways. The system can be configured to have diagnostic functionality but does not allow or enable direct diagnosis. No decisive information for making a diagnosis can be provided by the system on its own and it cannot provide diagnosis by itself, nor does it perform as a clinician or provide an indicative diagnosis to the lay user.
FUTURE HEALTH WORKS LTD
MD
In Commercial Distribution

  • G333OUG001 ()


  • Configurable electronic form web-based application software
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