AccessGUDID - DEVICE: reSET® Non-Monetary CM (10196439000012)

GUDID

Device Identifier (DI) Information

Brand Name: reSET® Non-Monetary CM
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N/A
Company Name: PEAR THERAPEUTICS, INC.

Primary DI Number: 10196439000012
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079705123 *Terms of Use

Device Description: 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 to patients based on the Contingency management system.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58290	Psychological assessment software	A screen-based (non-virtual-reality) software program intended to be used by patients and medical professionals to evaluate and determine the psychological profile of the patient; it may in addition be used to monitor the effectiveness and progress of psychotherapy, however it is not primarily intended to provide interactive therapy. It typically uses psychological tests/questionnaires and patient demographics (e.g., smartphone digital phenotype) to establish a mental wellbeing score, and may also provide resources to promote patient awareness and recovery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PWE	Computerized Behavioral Therapy Device For Psychiatric Disorders

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN160018	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d29da6cb-27a8-4a6c-a97d-755482644692
Public Version Date: October 24, 2022
Public Version Number: 2
DI Record Publish Date: June 08, 2022