LivRing(R)

GUDID 20860009126408

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.

J3 Bioscience, Inc.

Sexual lubricant

• Primary Device ID: 20860009126408
• NIH Device Record Key: 0b46e53d-bfed-4538-a1d6-9cc43918e275
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LivRing(R)
• Version Model Number: VR101
• Company DUNS: 829949788
• Company Name: J3 Bioscience, Inc.
• Device Count: 4
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009126404 [Primary]
GS1	10860009126401 [Unit of Use]
GS1	20860009126408 [Package]; Contains: 00860009126404; Package: Shipping Carton [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203377

FDA Product Code

• QPD: Personal Lubricant Ring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-02-10
• Device Publish Date: 2024-10-07