reSET-O®

GUDID 10851580008101

reSET-O® is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.

PEAR THERAPEUTICS, INC.

Cognitive therapy software

• Primary Device ID: 10851580008101
• NIH Device Record Key: d9f8f95f-7e8d-4868-a141-3168d540d714
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: reSET-O®
• Version Model Number: 1
• Company DUNS: 079705123
• Company Name: PEAR THERAPEUTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10851580008101 [Primary]
NDC/NHRIC	96439-0020-01 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173681

FDA Product Code

• PWE: Computerized Behavioral Therapy Device For Psychiatric Disorders

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-23
• Device Publish Date: 2019-07-15

On-Brand Devices [reSET-O®]

• 10851580008101: reSET-O® is intended to increase retention of patients with opioid use disorder (OUD) in outpat
• 10196439000029: reSET-O is intended to increase retention of patients with Opioid Use Disorder (OUD) in outpatie