Identity
- Trade Name
- Mahana IBS FDA UDI
- Generic Name
- Mental health/function therapeutic software, screen-viewed FDA UDI
- Device Name
- Mahana IBS is a prescription Digital Therapeutic (PDT) mobile application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS). FDA UDI
- Model / Reference
- 01-0003-001 FDA UDI
- Description
- Mahana IBS is a prescription Digital Therapeutic (PDT) mobile application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS). FDA UDI
Identifiers
- Catalog Number
- 01-0003-001 FDA UDI
- Primary DI / UDI-DI
- 00860006172015 FDA UDI
- 510(k) Number
- K211372 FDA UDI
- FDA Product Code
- QMY FDA UDI
- GMDN Term
- Mental health/function therapeutic software, screen-viewed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5960 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mental health/function therapeutic software, screen-viewed
Mahana IBS by Mahana Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Mahana Therapeutics, Inc.
Sources (1)
- FDA UDI a0e4bc2d-8ac0-4f86-9b36-d814501ae91b 36 fields · synced May 30, 2026