PursueCare RESET-O

GUDID 00850074433026

RESET-O is an Android application intended to increase retention of opioid use disorder patients in outpatient treatment by providing cognitive behavioral therapy as a adjunct to outpatient treatment.

Harvest Bio LLC

Mental health/function therapeutic software, screen-viewed

• Primary Device ID: 00850074433026
• NIH Device Record Key: c3245ca7-2a5c-4579-ad99-ca46325e5d23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PursueCare RESET-O
• Version Model Number: 2.0.2
• Company DUNS: 118987662
• Company Name: Harvest Bio LLC
• 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	00850074433026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173681

FDA Product Code

• PWE: Computerized Behavioral Therapy Device For Substance Use 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: 2025-05-06
• Device Publish Date: 2025-04-28

On-Brand Devices [PursueCare RESET-O]

• 00850074433026: RESET-O is an Android application intended to increase retention of opioid use disorder patients
• 00850074433019: RESET-O is an iOS application intended to increase retention of opioid use disorder patients in