Astroglide Organix Gel

GUDID 00015594011660

Astroglide Organix 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 condoms. It is not compatible with polyisoprene, and polyurethane condoms.

BIOFILM, INC

Sexual lubricant
Primary Device ID00015594011660
NIH Device Record Key78327ec4-d1ab-4237-957e-ee453c9db58d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAstroglide Organix Gel
Version Model Number015594011660
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
Phone1-800-848-5900
Emailcustomer.service@biofilm.com
Phone1-800-848-5900
Emailcustomer.service@biofilm.com

Device Dimensions

Weight85 Gram
Weight85 Gram
Weight85 Gram
Weight85 Gram
Weight85 Gram
Weight85 Gram
Weight85 Gram
Weight85 Gram
Weight85 Gram
Weight85 Gram
Weight85 Gram
Weight85 Gram
Weight85 Gram
Weight85 Gram
Weight85 Gram
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
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
GS100015594011660 [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 Date2022-02-23
Device Publish Date2022-02-15

Devices Manufactured by BIOFILM, INC

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