FDA UDI
In Commercial Distribution
🇺🇸 United States
Vibrant Pod
DI: 00860009189812
·
Model: 1
·
VIBRANT LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vibrant Pod
- Primary DI
- 00860009189812
- 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
- 88d69560-c2bb-4392-be5e-876455f66f40
Device Description
The Pod is a reusable Capsule activation unit. Patients use the Pod to activate Capsules at home. USB cable and AC/DC USB adaptor provided with the Pod.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| QTN | Orally Ingested Transient Device For Constipation | Gastroenterology, Urology | 876.5940 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66618 | Internal gastrointestinal vibratory-stimulation system activation unit | A noninvasive, electrically-powered component of an internal gastrointestinal vibratory-stimulation system intended to activate an ingestible capsule (not included) prior to swallowing. Typically a small portable unit, it is intended to transmit a pre-programmed vibration protocol (vibration duration and resting stages) to the capsule but is not intended to modify the protocol parameters (i.e., not a programmer). Typically considered a complimentary therapy device, it is intended for use in both the home and clinical setting. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860009189812 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN210052 | 000 |