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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Blood Glucose Test strips. Sold in a carton with a single bottle (50 test strips - RDC # 0193-7080-50), or in a carton of two bottles (100 test strips total - RDC # 0193-7090-21).
ASCENSIA DIABETES CARE US INC.
7080G
In Commercial Distribution

  • 40301939727210 ()
  • 00301937090219 ()
  • 10301937080507 ()
  • 40301939726503 ()
  • 00301937080500 ()
  • 40301937090217 ()
  • 40301937080508 ()
  • 0193-7080-50 ()
  • 00301937080012 ()
  • 40301939603040 ()
  • 40301939602043 ()
6707113

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).
ASCENSIA DIABETES CARE US INC.
1468A
Not in Commercial Distribution

  • 40301931468500 ()
  • 00301931468502 ()
  • 10301931468509 ()
  • 20301931468506 ()
  • 0193-1468-50 ()
  • 00301931468014 ()
56853247

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).
ASCENSIA DIABETES CARE US INC.
1467A
Not in Commercial Distribution

  • 40301931467503 ()
  • 00301931467505 ()
  • 10301931467502 ()
  • 20301931467509 ()
  • 0193-1467-50 ()
  • 00301931467017 ()
56853239

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips. Sold in a carton of 100 Test Strips (10 Discs).
ASCENSIA DIABETES CARE US INC.
1466A
Not in Commercial Distribution

  • 00301931466218 ()
  • 10301931466215 ()
  • 20301931466212 ()
  • 0193-1466-21 ()
  • 00301931466010 ()
  • 40301931466216 ()
56853220

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).
ASCENSIA DIABETES CARE US INC.
1465A
Not in Commercial Distribution

  • 40301931465509 ()
  • 00301931465501 ()
  • 10301931465508 ()
  • 20301931465505 ()
  • 0193-1465-50 ()
  • 00301931465013 ()
56853212

  • Glucose monitoring system IVD, home-use
Somryst is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia - CBT-I) in patients 22 years of age and older with chronic insomnia. Somryst treats chronic insomnia by improving a patient's insomnia symptoms. Somryst uses sleep restriction and consolidation, limiting the time a patient spends in bed to match the amount of time they sleep. This treatment technique can increase risks to some patients whose pathophysiology may be worsened. Because of this, it is not appropriate for everyone.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008255 ()
  • 96439-0030-01 ()


  • Mental health/function therapeutic software, screen-viewed
Blood Glucose Test Strips - 50 Test Strips (per bottle) - sold in a carton of 2 bottles (100 test strips total).
ASCENSIA DIABETES CARE US INC.
7312
In Commercial Distribution

  • 40301939737219 ()
  • 00301937312212 ()
  • 10301937312219 ()
  • 40301937312210 ()
  • 0193-7312-21 ()
  • 00301937312014 ()
  • 40301935541049 ()
  • 40301939770513 ()
83624788

  • Glucose monitoring system IVD, home-use
FreeStyle Precision Pro Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
71284
In Commercial Distribution

  • 30093815712849 ()
  • 00093815712848 ()
  • 57599-1284-5 ()
  • 10093815712845 ()
71284

  • Multiple clinical chemistry analyte monitoring system IVD, point-of-care
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
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) prescription-only 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.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008071 ()
  • 96439-0010-01 ()


  • Mental health/function therapeutic software, screen-viewed
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