LivRing(R)
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- LivRing(R)
- Primary DI
- 00860009126404
- Version / Model
- VR101
- Company Name
- J3 Bioscience, Inc.
- Labeler DUNS
- 829949788
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2024-10-07
- Public Version
- 2
- Public Version Date
- 2025-02-10
- Public Version Status
- Update
- Public Device Record Key
- 0b46e53d-bfed-4538-a1d6-9cc43918e275
Device Description
The VR101 Lubricating Intravaginal Ring device is a lubricating intravaginal ring designed to relieve the symptoms of vaginal dryness. VR101 Lubricating Intravaginal Ring is constructed from a hollow biomedical grade hydrophilic polyether urethane (HPU) tube filled with a liquid vaginal lubricating solution comprised of a solution of glycerol (also known as glycerin), water, and sodium chloride. Upon insertion of VR101 Lubricating Intravaginal Ring in the vagina, the lubricating solution in the lumen ring is released through the semi-permeable wall of the tubing into the vagina, moisturizing and lubricating the vaginal mucosa without the use of any hormones or active pharmaceutical ingredients (APIs). Each VR101 Lubricating Intravaginal Ring provides moisturization and lubrication for up to seven (7) days.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| QPD | Personal Lubricant Ring | Obstetrics/Gynecology | 884.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60412 | Sexual lubricant | A substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20860009126408 | GS1 | Shipping Carton | 30 | In Commercial Distribution | |
| Primary | 00860009126404 | GS1 | ||||
| Unit of Use | 10860009126401 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203377 | 000 |