Device
Water-soluble Personal Lubricant is a water basedpersonallubricant, for penile and/or vaginal application,intended to lubricateand moisturize, toenhance the ease and comfort of int...
Manufacturer
Shenzhen Yongquan Medical Devices Co., Ltd.
Shenzhen Yongquan Medical Devices Co., Ltd.
Model: 16 FL.OZ
DI: 06979879080151
Status: Update
MRI: MR Unsafe
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-25
Description
Water-soluble Personal Lubricant is a water basedpersonallubricant, for penile and/or vaginal application,intended to lubricateand moisturize, toenhance the ease and comfort of intimate sexual activity andsupplement the body'snatural lubrication. This product is not compatible withnatural rubber latex, polyurethane,and polyisoprene condoms
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
c4cee1fe-de07-454a-9bcd-9947b97918c4
Distribution Status:
In Commercial Distribution
DUNS Number:
550369639
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06979879080151
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 34131
Name: Vaginal lubricant
Definition:
A non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused.
FDA Product Codes
NUC
Lubricant, Personal
Premarket Submissions
Submission Number:
K251773
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Item #1 - Storage Handling Low - @attributes - Value:
56
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Item #1 - Storage Handling High - @attributes - Value:
86
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Item #2 - Storage Handling Low - @attributes - Value:
59
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Item #2 - Storage Handling High - @attributes - Value:
86
Item #2 - Storage Handling Type:
Handling Environment Temperature