FDA UDI
In Commercial Distribution
🇺🇸 United States
VIVE
DI: 00818323028966
·
Model: LVA2026
·
VIVE HEALTH LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- VIVE
- Primary DI
- 00818323028966
- Version / Model
- LVA2026
- Company Name
- VIVE HEALTH LLC
- Labeler DUNS
- 047025993
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-28
- Public Version
- 1
- Public Version Date
- 2019-09-05
- Public Version Status
- New
- Public Device Record Key
- 36390ecb-8b28-497b-8649-d2f6fa6e762c
Device Description
Water Flosser
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| EFS | Unit, Oral Irrigation | Dental | 872.6510 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63585 | Water jet flosser | An electrically-powered device intended to provide a high-pressure water jet for dental flossing (removal of plaque and/or debris from between teeth) using a dedicated handpiece. It is normally available [non-prescription] over-the-counter (OTC) fo use in the home or healthcare facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10818323028963 | GS1 | Case | 30 | In Commercial Distribution | |
| Primary | 00818323028966 | GS1 |