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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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reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12-week (90 days) prescriptiononly treatment for patients with Substance Use Disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to: increase abstinence from a patient’s substances of abuse during treatment, and increase retention in the outpatient treatment program. This configuration of reSET is intended to provide virtual incentives as well as monetary incentives to the patients based on the Contingency management system.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10196439000005 ()
N/A

  • Psychological assessment software
No Description
Imeka Solutions Inc
1
In Commercial Distribution

  • 00754016387111 ()


  • Radiological PACS software
POSTOPERATIVE MOBILE PATIENT APPLICATION SW
ORTHOFIX SRL
1.0
In Commercial Distribution

  • 18052469476451 ()
MYHEXPLANSW

  • Radiological PACS software
Digistat Smart Central is an on-site integration solution which forwards medical device status and alarm information to the user via display devices provided by Ascom or third-party companies. Users receive, time-critical information from connected medical devices directly via their display devices as text, alarms or data. Digistat Smart Central allows users to be aware of their patients’ status and alarm conditions when they are away from the patient and associated medical devices.
ASCOM UMS SRL
SW000754
In Commercial Distribution

  • 17350097870032 ()


  • Alarm application software
No Description
Ascom (Sweden) AB
Unite Connect for Clinical Systems
In Commercial Distribution

  • 17350088671273 ()
SW000466

  • Alarm application software
No Description
Ascom (Sweden) AB
Cardiomax
In Commercial Distribution

  • 17350088670016 ()
SW000466

  • Alarm application software
No Description
Ascom (Sweden) AB
Mobile Monitoring Gateway (MMG)
In Commercial Distribution

  • 17350088670009 ()
SW000400

  • Alarm application software
No Description
Change Healthcare Canada Company
14.2.2
In Commercial Distribution

  • 17540262180053 ()


  • Radiological PACS software
No Description
Change Healthcare Canada Company
14.2.1
In Commercial Distribution

  • 17540262180046 ()


  • Radiological PACS software
No Description
Change Healthcare Canada Company
14.2
In Commercial Distribution

  • 17540262180039 ()


  • Radiological PACS software
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