AspyreRx

GUDID 00860011146704

BT-001 (AspyreRx) is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to treat patients 18 years or older with type 2 diabetes.

Better Therapeutics, Inc.

Mental health/function therapeutic software, screen-viewed

• Primary Device ID: 00860011146704
• NIH Device Record Key: 043d2c0c-95c8-420c-949a-aaf5f4ac90b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AspyreRx
• Version Model Number: ma.1.0.0
• Company DUNS: 117816253
• Company Name: Better 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	00860011146704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN220058

FDA Product Code

• QXC: Diabetes Digital Therapeutic Device

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: 2023-10-24
• Device Publish Date: 2023-10-16