Device
This water-based warming lubricant glides smoothly over skin, deliveringlasting moisture with a gentle heat that builds as you move. Lightweight,comfortable, and easy to rinse, it'...
Manufacturer
Shenzhen Yongquan Medical Devices Co., Ltd.
Shenzhen Yongquan Medical Devices Co., Ltd.
Model: 5.3FL.OZ/150g
DI: 06959633106327
Status: Update
MRI: MR Unsafe
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-25
Description
This water-based warming lubricant glides smoothly over skin, deliveringlasting moisture with a gentle heat that builds as you move. Lightweight,comfortable, and easy to rinse, it's made for moments that deserve alittle extra
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
dd6d8d26-bc45-497e-b62b-c3726ad5ed9a
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:
06959633106327
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