Astroglide X Premium Silicone Gel Personal Lubricant N/A

GUDID 00015594011752

Astroglide X Premium Silicone Gel is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate activity and supplement the body’s natural lubrication. This product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

BIOFILM, INC

Sexual lubricant
Primary Device ID00015594011752
NIH Device Record Key5ded05e3-adab-4910-88c1-54633e55fc9f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAstroglide X Premium Silicone Gel Personal Lubricant
Version Model Number015594011752
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

Phone1-800-848-5900
Emailcustomer.service@biofilm.com
Phone1-800-848-5900
Emailcustomer.service@biofilm.com
Phone1-800-848-5900
Emailcustomer.service@biofilm.com
Phone1-800-848-5900
Emailcustomer.service@biofilm.com
Phone1-800-848-5900
Emailcustomer.service@biofilm.com
Phone1-800-848-5900
Emailcustomer.service@biofilm.com
Phone1-800-848-5900
Emailcustomer.service@biofilm.com
Phone1-800-848-5900
Emailcustomer.service@biofilm.com
Phone1-800-848-5900
Emailcustomer.service@biofilm.com
Phone1-800-848-5900
Emailcustomer.service@biofilm.com
Phone1-800-848-5900
Emailcustomer.service@biofilm.com
Phone1-800-848-5900
Emailcustomer.service@biofilm.com
Phone1-800-848-5900
Emailcustomer.service@biofilm.com
Phone1-800-848-5900
Emailcustomer.service@biofilm.com

Device Dimensions

Total Volume3 Fluid Ounce
Weight85 Gram
Total Volume3 Fluid Ounce
Weight85 Gram
Total Volume3 Fluid Ounce
Weight85 Gram
Total Volume3 Fluid Ounce
Weight85 Gram
Total Volume3 Fluid Ounce
Weight85 Gram
Total Volume3 Fluid Ounce
Weight85 Gram
Total Volume3 Fluid Ounce
Weight85 Gram
Total Volume3 Fluid Ounce
Weight85 Gram
Total Volume3 Fluid Ounce
Weight85 Gram
Total Volume3 Fluid Ounce
Weight85 Gram
Total Volume3 Fluid Ounce
Weight85 Gram
Total Volume3 Fluid Ounce
Weight85 Gram
Total Volume3 Fluid Ounce
Weight85 Gram
Total Volume3 Fluid Ounce
Weight85 Gram

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
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
GS100015594011752 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUCLubricant, Personal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-08-07
Device Publish Date2019-05-07

On-Brand Devices [Astroglide X Premium Silicone Gel Personal Lubricant]

00015594011752Astroglide X Premium Silicone Gel is a personal lubricant for penile and/or vaginal application,
00015594011769Astroglide X Premium Silicone Gel is a personal lubricant for penile and/or vaginal application,

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.