Astroglide X Silicone Liquid N/A

GUDID 00015594000046

Astroglide® X Silicone Personal Lubricant is a personal lubricant for penile, vaginal, and/or anal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms.

BIOFILM, INC

Sexual lubricant
Primary Device ID00015594000046
NIH Device Record Keya7ea7b2a-c8f0-4b8d-9e1b-9353c47f733b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAstroglide X Silicone Liquid
Version Model Number015594000046
Catalog NumberN/A
Company DUNS790780258
Company NameBIOFILM, INC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-431-2610
Emailsircmrof@combe.com
Phone1-800-431-2610
Emailsircmrof@combe.com
Phone1-800-431-2610
Emailsircmrof@combe.com
Phone1-800-431-2610
Emailsircmrof@combe.com
Phone1-800-431-2610
Emailsircmrof@combe.com
Phone1-800-431-2610
Emailsircmrof@combe.com
Phone1-800-431-2610
Emailsircmrof@combe.com
Phone1-800-431-2610
Emailsircmrof@combe.com
Phone1-800-431-2610
Emailsircmrof@combe.com
Phone1-800-431-2610
Emailsircmrof@combe.com
Phone1-800-431-2610
Emailsircmrof@combe.com
Phone1-800-431-2610
Emailsircmrof@combe.com

Device Dimensions

Total Volume12 Fluid Ounce
Total Volume12 Fluid Ounce
Total Volume12 Fluid Ounce
Total Volume12 Fluid Ounce
Total Volume12 Fluid Ounce
Total Volume12 Fluid Ounce
Total Volume12 Fluid Ounce
Total Volume12 Fluid Ounce
Total Volume12 Fluid Ounce
Total Volume12 Fluid Ounce
Total Volume12 Fluid Ounce
Total Volume12 Fluid Ounce

Operating and Storage Conditions

Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100015594000046 [Primary]

FDA Product Code

NUCLubricant, Personal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-14
Device Publish Date2025-07-05

On-Brand Devices [Astroglide X Silicone Liquid]

00015594010861Astroglide® X Silicone Personal Lubricant is a personal lubricant for penile, vaginal, and/or
00015594011837Astroglide® X Silicone Personal Lubricant is a personal lubricant for penile, vaginal, and/or
00015594012094Astroglide® X Silicone Personal Lubricant is a personal lubricant for penile, vaginal, and/or
00015594000046Astroglide® X Silicone Personal Lubricant is a personal lubricant for penile, vaginal, and/or

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.