Home GUDID 10851580008026
reSET®
Primary DI 10851580008026
Brand reSET®
Company PEAR THERAPEUTICS, INC.
Model 1.5
Catalog number N/A
Device description reSET Mobile Application runs on iOS. 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.
Published 2018-07-12
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name PWE Cognitive Behavioral Therapy Device For Psychiatric Disorders
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PWE Computerized Behavioral Therapy Device For Substance Use Disorders Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10851580008026 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10851580008026 10851580008026
GMDN Terms# Term, Definition table Term Definition Cognitive therapy software A software program intended to be used with an off-the-shelf computer/tablet/smartphone to help improve a cognitive function (e.g., attention/concentration, memory, eye movement training to improve reading ability) by providing a patient with on-screen interactive sessions (e.g., text for audible reading); it is not intended to detect/display a patient’s physical movements/actions. It may additionally be designed to screen for cognitive disorders, set baselines, and will typically show development (i.e., interactive). It is intended to be used by parents, educators, specialists and medical professionals at home, school or in a clinical setting.
Regulatory Flags# DUNS number 079705123 Device count 1 Lot or batch true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10851580008255 Somryst™ 1 2020-09-09 10851580008019 reSET® 1.4.6 2017-12-11 10851580008040 reSET® 1.4 2018-07-12 10851580008132 reSET® Introductory Access Limited Version 1 2019-08-25 10851580008149 reSET® Introductory Access Limited Version (Mobile App, iOS) 1 2019-08-25 10851580008156 reSET® Introductory Access Limited Version (Mobile App, Android) 1 2019-08-25 10851580008163 reSET-O® Introductory Access Limited Version 1 2019-08-25 10851580008170 reSET-O® Introductory Access Limited Version (Mobile App, iOS) 1 2019-08-25 10851580008187 reSET-O® Introductory Access Limited Version (Mobile App, Android) 1 2019-08-25 10851580008194 reSET® Demo Version 1 2019-11-25 10851580008200 reSET® Demo Version (Mobile App, iOS) 1 2019-11-25 10851580008217 reSET® Demo Version (Mobile App, Android) 1 2019-11-25 10851580008224 reSET-O® Demo Version 1 2019-11-25 10851580008231 reSET-O® Demo Version (Mobile App, iOS) 1 2019-11-25 10851580008248 reSET-O® Demo Version (Mobile App, Android) 1 2019-11-25 10851580008033 reSET® 1.5 N/A 2018-07-12 10851580008057 reSET-O™ 1.1 N/A 2018-12-26 10851580008064 reSET-O™ 1.1 N/A 2018-12-26 10851580008071 reSET® 1 2019-07-15 10851580008088 reSET® Mobile App, iOS 1 2019-07-15
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850074433002 PursueCare RESET Harvest Bio LLC PWE 2025-04-28 00850074433019 PursueCare RESET-O Harvest Bio LLC PWE 2025-04-28 00850074433026 PursueCare RESET-O Harvest Bio LLC PWE 2025-04-28 00850074433033 PursueCare RESET Harvest Bio LLC PWE 2025-04-28 10196439000005 reSET® PEAR THERAPEUTICS, INC. PWE 2022-06-08 10196439000012 reSET® Non-Monetary CM PEAR THERAPEUTICS, INC. PWE 2022-06-08 10196439000029 reSET-O® PEAR THERAPEUTICS, INC. PWE 2022-06-08 10196439000036 reSET-O® Non-Monetary CM PEAR THERAPEUTICS, INC. PWE 2022-06-08 10851580008255 Somryst™ PEAR THERAPEUTICS, INC. PWE 2020-09-09 10851580008194 reSET® Demo Version PEAR THERAPEUTICS, INC. PWE 2019-11-25 10851580008200 reSET® Demo Version (Mobile App, iOS) PEAR THERAPEUTICS, INC. PWE 2019-11-25 10851580008217 reSET® Demo Version (Mobile App, Android) PEAR THERAPEUTICS, INC. PWE 2019-11-25 10851580008224 reSET-O® Demo Version PEAR THERAPEUTICS, INC. PWE 2019-11-25 10851580008231 reSET-O® Demo Version (Mobile App, iOS) PEAR THERAPEUTICS, INC. PWE 2019-11-25 10851580008248 reSET-O® Demo Version (Mobile App, Android) PEAR THERAPEUTICS, INC. PWE 2019-11-25 10851580008132 reSET® Introductory Access Limited Version PEAR THERAPEUTICS, INC. PWE 2019-08-25 10851580008149 reSET® Introductory Access Limited Version (Mobile App, iOS) PEAR THERAPEUTICS, INC. PWE 2019-08-25 10851580008156 reSET® Introductory Access Limited Version (Mobile App, Android) PEAR THERAPEUTICS, INC. PWE 2019-08-25 10851580008163 reSET-O® Introductory Access Limited Version PEAR THERAPEUTICS, INC. PWE 2019-08-25 10851580008170 reSET-O® Introductory Access Limited Version (Mobile App, iOS) PEAR THERAPEUTICS, INC. PWE 2019-08-25 10851580008187 reSET-O® Introductory Access Limited Version (Mobile App, Android) PEAR THERAPEUTICS, INC. PWE 2019-08-25 10851580008071 reSET® PEAR THERAPEUTICS, INC. PWE 2019-07-15 10851580008088 reSET® Mobile App, iOS PEAR THERAPEUTICS, INC. PWE 2019-07-15 10851580008095 reSET® Mobile App, Android PEAR THERAPEUTICS, INC. PWE 2019-07-15 10851580008101 reSET-O® PEAR THERAPEUTICS, INC. PWE 2019-07-15 10851580008118 reSET-O® Mobile App, iOS PEAR THERAPEUTICS, INC. PWE 2019-07-15 10851580008125 reSET-O® Mobile App, Android PEAR THERAPEUTICS, INC. PWE 2019-07-15 10851580008057 reSET-O™ PEAR THERAPEUTICS, INC. PWE 2018-12-26 10851580008064 reSET-O™ PEAR THERAPEUTICS, INC. PWE 2018-12-26 10851580008040 reSET® PEAR THERAPEUTICS, INC. PWE 2018-07-12