FDA UDI
In Commercial Distribution
🇺🇸 United States
Vibrant Starter Kit
DI: 00860009189829
·
Model: 1
·
VIBRANT LTD
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vibrant Starter Kit
- Primary DI
- 00860009189829
- 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
- c31d47c5-72ab-4a46-9a16-e4793c61e955
Device Description
The starter kit contains a Pod (with USB cable and AC/DC USB adaptor) and 2 blisters of capsules: 10 capsules/ blister (total of 20 capsules).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66616 | Internal gastrointestinal vibratory-stimulation system | An assembly of electrically-powered devices intended to apply mechanical vibrations to the gastrointestinal (GI) tract internally to stimulate peristalsis and bowel evacuation (e.g., to treat constipation). It consists of a disposable, ingestible vibrating capsule intended to be introduced into, and stimulate, the (GI) tract, and a capsule activation unit designed to activate the capsule with the required vibration protocol (vibration duration and resting stages) prior to swallowing. Typically considered a complimentary therapy device, it is intended for use in both the home and clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860009189829 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN210052 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius