Astroglide O Oil Personal Lubricant & Massage Oil N/A

GUDID 00015594011417

Astroglide O Oil Personal Lubricant & Massage Oil 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 NOT compatible with condoms.

BIOFILM, INC

Sexual lubricant
Primary Device ID00015594011417
NIH Device Record Key50615db4-5cc3-472f-9591-c034e4931cee
Commercial Distribution StatusIn Commercial Distribution
Brand NameAstroglide O Oil Personal Lubricant & Massage Oil
Version Model Number015594011417
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 Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 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
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
GS100015594011417 [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 Date2018-11-20

Devices Manufactured by BIOFILM, INC

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00015594011776 - Astroglide Glycerin & Paraben Free Personal Lubricant2023-06-15 Astroglide Glycerin & Paraben Free is a personal lubricant for penile, vaginal, and/or anal application intended to moisturize a

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