FDA UDI
In Commercial Distribution
🇺🇸 United States
SleepioRx
DI: 00860008033024
·
Model: v1
·
Big Health Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SleepioRx
- Primary DI
- 00860008033024
- Version / Model
- v1
- Company Name
- Big Health Inc.
- Labeler DUNS
- 079826953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-14
- Public Version
- 2
- Public Version Date
- 2025-11-20
- Public Version Status
- Update
- Public Device Record Key
- 3b30cd30-60f1-49f1-b158-8023c265dc06
Device Description
SleepioRx is a digital therapeutic intended for the treatment of chronic insomnia / insomnia disorder as an adjunct to usual care in patients aged 18 and older. SleepioRx is a prescription device delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) and can be made available on the order of a licensed healthcare provider.
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QVO | Computerized Behavioral Therapy Device For Insomnia | Neurology | 882.5801 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63031 | Mental health/function therapeutic software, screen-viewed | A screen-based (non-virtual-reality) software program intended to be used with an off-the-shelf computer/smart device to help improve mental health/wellbeing (e.g., control effects of mood disorders, stress) and/or a cognitive function (e.g., concentration, memory, eye movement training to improve reading, speech) by providing a patient with on-screen interactive sessions. It may additionally be designed to assess cognition/mental health, set baselines, help manage pain, and will typically track development (i.e., interactive). It is not intended for kinesiology-based neuromuscular rehabilitation. It is intended to be used by the patient and may involve clinical assistance/recommendations. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860008033024 | GS1 |
Customer Contacts
- Phone
- (707) 563-1049
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233577 | 000 |