| Primary Device ID | 00860006172015 |
| NIH Device Record Key | a0e4bc2d-8ac0-4f86-9b36-d814501ae91b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mahana IBS |
| Version Model Number | 01-0003-001 |
| Catalog Number | 01-0003-001 |
| Company DUNS | 081128158 |
| Company Name | Mahana 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860006172015 [Primary] |
| QMY | Computerized Behavioral Therapy Device For Treating Symptoms |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-29 |
| Device Publish Date | 2021-06-21 |
| 00860006172015 - Mahana IBS | 2021-06-29Mahana IBS is a prescription Digital Therapeutic (PDT) mobile application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS). |
| 00860006172015 - Mahana IBS | 2021-06-29 Mahana IBS is a prescription Digital Therapeutic (PDT) mobile application designed to deliver Cognitive Behavioral Therapy (CBT) |
| 00860006172008 - Parallel(TM) | 2021-03-26 ParallelTM is a Prescription Digital Therapeutic (PDT) web application designed to deliver Cognitive Behavioral Therapy (CBT) to |