Rejoyn (also known as CT-152) is a digital therapeutic smartphone application (app) for the treatment of Major Depressive Disorder (MDD) symptoms. Rejoyn is a prescription smartphone app-based digital therapeutic administered to a user via the user’s smartphone device (running Apple iPhone operating system [iOS®] or Android™ operating system [OS]), which delivers a proprietary interactive cognitive emotional and behavioral therapeutic intervention. The core components of Rejoyn are the Emotional Faces Memory Task (EFMT) exercises, brief cognitive behavioral therapy (CBT)-based lessons to learn and apply key therapeutic skills, and short message service (SMS) text messaging to reinforce CBT-based lesson content and to encourage engagement with the app. It is intended for the treatment of MDD symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older. It is intended to reduce MDD symptoms. Rejoyn is designed for use as an adjunct to clinician-managed outpatient care over a period of 6 weeks for the treatment of MDD symptoms, followed by a 4-week extension period where CBT-based lesson content will be accessible but no new therapeutic content or EFMT exercises will be available. Rejoyn is not intended to be used as a stand-alone therapy or as a substitution for the patient’s clinician prescribed medications.
Otsuka Pharmaceutical Development & Commercialization, Inc.
CT-152
In Commercial Distribution

  • 00857335005121 ()
  • 57335-0005-12 ()
57335000512

  • Mental health/function therapeutic software, screen-viewed
Abbott SF Single Use Lancing Device 200ct, US
ABBOTT DIABETES CARE INC
78632
In Commercial Distribution

  • 10357599000698 ()
  • 57599-0833-00 ()
  • 00357599833008 ()
  • 30357599833009 ()
78632

  • Manual blood lancing device, single-use
Prodigy No Coding Blood Glucose Test Strips (100 ct) with FREE AutoCode meter.for eCommerce
Prodigy Diabetes Care, LLC
010500
In Commercial Distribution

  • 00384840105003 ()
  • 00384841104005 ()
  • 00384844105009 ()
  • 3 84840 10500 ()
010500

  • Glucose monitoring system IVD, home-use
1 Box of Prodigy No Coding Blood Glucose Test Strips for eCommerce (50 ct)
Prodigy Diabetes Care, LLC
010400
In Commercial Distribution

  • 00384843104003 ()
  • 00384840104006 ()
  • 00384844104002 ()
  • 3 84840 10400 ()
010400

  • Glucose IVD, kit, electrometry
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE Meter; 20 CONTOUR® NEXT Blood Glucose Test Strips; MICROLET® NEXT Lancing Device; 20 MICROLET® Lancets; User Guide; Quick Reference Guide; Carrying Case
ASCENSIA DIABETES CARE US INC.
7828
In Commercial Distribution

  • 40301937828018 ()
  • 00301937828010 ()
  • 0193-7828-01 ()
90007942

  • Glucose monitoring system IVD, home-use
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE Meter; MICROLET® NEXT Lancing Device; 10 MICROLET® Lancets; User Guide; Quick Reference Guide; Carrying Case
ASCENSIA DIABETES CARE US INC.
7825
In Commercial Distribution

  • 40301937825017 ()
  • 00301937825019 ()
  • 0193-7825-01 ()
90007939

  • Glucose monitoring system IVD, home-use
FreeStyle Unistik 2
ABBOTT DIABETES CARE INC
70428
In Commercial Distribution

  • 30093815704288 ()
  • 00093815704287 ()
  • 99073-0704-28 ()
  • 10093815704284 ()
70428

  • Glucose monitoring system IVD, home-use
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