FDA UDI
In Commercial Distribution
🇺🇸 United States
Parallel(TM)
DI: 00860006172008
·
Model: 01-0001-001
·
Mahana Therapeutics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Parallel(TM)
- Primary DI
- 00860006172008
- Version / Model
- 01-0001-001
- Catalog Number
- 01-0001-001
- Company Name
- Mahana Therapeutics, Inc.
- Labeler DUNS
- 081128158
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-18
- Public Version
- 1
- Public Version Date
- 2021-03-26
- Public Version Status
- New
- Public Device Record Key
- 685638e8-f631-44bf-9116-56ee90e2f899
Device Description
ParallelTM is a Prescription Digital Therapeutic (PDT) web application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QMY | Computerized Behavioral Therapy Device For Treating Symptoms | Gastroenterology, Urology | 876.5960 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65220 | Mindfulness/behavioural therapy software, non-clinician-consultative | A software program intended to be used with an off-the-shelf computer/tablet/smartphone to help treat affective/mood disorders, stress, and/or other disorders related to or caused by these, by providing a patient with on-screen therapeutic exercises (e.g., mindfulness, mental imagery, cognitive behavioural therapy) often with educational information; it is not dedicated to exposure therapy. It is intended for use by a patient at home and is not based on consultation with a clinician. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860006172008 | GS1 |
Customer Contacts
- Phone
- 844-624-2620
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN200029 | 000 |