LivRing(R)

Primary DI
00860009126404
Brand
LivRing(R)
Company
J3 Bioscience, Inc.
Model
VR101
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.
Published
2024-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
QPDPersonal Lubricant Ring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPDPersonal Lubricant RingObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203377000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203377000VR101 Lubricating Intravaginal RingJ3 Bioscience, Inc.2021-05-20QPD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20860009126408PackageGS130In Commercial Distribution
00860009126404PrimaryGS10
10860009126401Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086000912640820860009126408
00860009126404008600091264048600091264040860009126404
1086000912640110860009126401

GMDN Terms#

Term, Definition table
TermDefinition
Sexual lubricantA 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.

Regulatory Flags#

DUNS number
829949788
Device count
4
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20860009126408LivRing(R)VR1012024-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20860009126408LivRing(R)J3 Bioscience, Inc.QPD2024-10-07