Astroglide Gel Personal Lubricant

GUDID 00015594012148

Astroglide Gel is a personal lubricant for penile and/or vaginal 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 and polyurethane condoms.

BIOFILM, INC

Sexual lubricant
Primary Device ID00015594012148
NIH Device Record Keye5a8c160-6750-4c6e-b59b-9741d01d48c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameAstroglide Gel Personal Lubricant
Version Model Number015594012148
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
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

Weight198 Gram
Weight198 Gram
Weight198 Gram
Weight198 Gram
Weight198 Gram
Weight198 Gram
Weight198 Gram
Weight198 Gram
Weight198 Gram
Weight198 Gram
Weight198 Gram
Weight198 Gram
Weight198 Gram
Weight198 Gram
Weight198 Gram
Weight198 Gram
Weight198 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
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
GS100015594012148 [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 Date2024-08-29
Device Publish Date2024-08-21

On-Brand Devices [Astroglide Gel Personal Lubricant]

00015594010106Astroglide Gel is a personal lubricant for penile and/or vaginal application, intended to moistu
00015594011851Astroglide Gel is a personal lubricant for penile and/or vaginal application, intended to moistu
00015594012148Astroglide Gel is a personal lubricant for penile and/or vaginal application, intended to moistu

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