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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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Chromosome Analysis Suite Dx Software
Affymetrix, Inc.
1.2
In Commercial Distribution

  • 00856826006074 ()
610525

  • Human genomic analysis interpretive software
Chromosome Analysis Suite Dx Software
Affymetrix, Inc.
2.1
In Commercial Distribution

  • 00856826006210 ()
610525

  • Human genomic analysis interpretive software
SleepioRx is a digital therapeutic intended for the treatment of chronic insomnia / insomnia disorder as an adjunct to usual care in patients aged 18 and older. SleepioRx is a prescription device delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) and can be made available on the order of a licensed healthcare provider.
Big Health Inc.
v1
In Commercial Distribution

  • 00860008033024 ()


  • Mental health/function therapeutic software, screen-viewed
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
Mahana IBS is a prescription Digital Therapeutic (PDT) mobile application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS).
Mahana Therapeutics, Inc.
01-0003-001
In Commercial Distribution

  • 00860006172015 ()
01-0003-001

  • Mental health/function therapeutic software, screen-viewed
23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Reports, Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP)), Pharmacogenetics, SLCO1B1 Pharmacogenetic Report Update and medication insights, NonSyndromic Hearing Loss Carrier Status Report, Sickle Cell Carrier Status Report Update, Hereditary Prostate Cancer (HOXB13-Related), SLCO1B1 Pharmacogenetic Report Update and medication insight
23ANDME, INC.
YouDot
Not in Commercial Distribution

  • 00859462006408 ()


  • Human genomic analysis interpretive software
23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Reports, Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP)), Pharmacogenetics, and Medication Insights Reports, NonSyndromic Hearing Loss Carrier Status Report, Sickle Cell Carrier Status Report Update
23ANDME, INC.
YouDot
Not in Commercial Distribution

  • 00859462006385 ()


  • Human genomic analysis interpretive software
23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Reports, Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP)), Pharmacogenetics, and Medication Insights Reports
23ANDME, INC.
YouDot
Not in Commercial Distribution

  • 00859462006262 ()


  • Human genomic analysis interpretive software
23andMe Personal Genome Service® (PGS) Includes : Carrier Status Report Genetic Health Risk Reports BRCA1/BRCA2 (Selected Variants)
23ANDME, INC.
YouDot
Not in Commercial Distribution

  • 00859462006095 ()
n/a

  • Human genomic analysis interpretive software
23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Reports, Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP)), Pharmacogenetics, CYP2C19 Pharmacogenetic Report Update and medication insights, NonSyndromic Hearing Loss Carrier Status Report, Sickle Cell Carrier Status Report Update, Hereditary Prostate Cancer (HOXB13-Related), SLCO1B1 Pharmacogenetic Report Update and medication insight, BRCA1/BRCA2 (Selected Variants) report update
23ANDME, INC.
YouDot
In Commercial Distribution

  • 00859462006415 ()


  • Human genomic analysis interpretive software
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