FDA UDI
In Commercial Distribution
🇺🇸 United States
20 Vibrant capsules
DI: 00860009189805
·
Model: 1
·
VIBRANT LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 20 Vibrant capsules
- Primary DI
- 00860009189805
- Version / Model
- 1
- Company Name
- VIBRANT LTD
- Labeler DUNS
- 532222218
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-15
- Public Version
- 1
- Public Version Date
- 2022-12-23
- Public Version Status
- New
- Public Device Record Key
- f0b8c186-bb5a-45fe-81f8-d153d0926ec8
Device Description
The Vibrant Capsule is a small dimension, easy to swallow capsule, bearing pre-programed stimulations specifically designed for individuals with chronic constipation. Each box contains 2 blisters with capsules. Each blister contains 10 capsules.
Device Characteristics
- Single Use
- Yes
- 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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| QTN | Orally Ingested Transient Device For Constipation | Gastroenterology, Urology | 876.5940 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66617 | Internal gastrointestinal vibratory-stimulation system capsule | A small, battery-powered, ingestible component of an internal gastrointestinal vibratory-stimulation system intended to be introduced into the gastrointestinal (GI) tract via the oral cavity to produce mechanical vibrations for stimulation of peristalsis and bowel evacuation (e.g., to treat constipation). It is in the form of a capsule that incorporates an electromechanical motor and processor. Typically considered a complimentary therapy device, it is intended for use in both the home and clinical setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860009189805 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN210052 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius