Identity
- Trade Name
- LivRing(R) FDA UDI
- Generic Name
- Sexual lubricant FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- VR101 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009126404 FDA UDI
- 510(k) Number
- K203377 FDA UDI
- FDA Product Code
- QPD FDA UDI
- GMDN Term
- Sexual lubricant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sexual lubricant
LivRing(R) by J3 Bioscience, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- J3 Bioscience, Inc.
Sources (1)
- FDA UDI 0b46e53d-bfed-4538-a1d6-9cc43918e275 34 fields · synced Jun 8, 2026