Astroglide Glycerin & Paraben Free Personal Lubricant NA

GUDID 00015594011776

Astroglide Glycerin & Paraben Free 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 compatibly with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

BIOFILM, INC

Sexual lubricant
Primary Device ID00015594011776
NIH Device Record Key761e0c95-62e2-4c2e-b981-c774b36d2424
Commercial Distribution StatusIn Commercial Distribution
Brand NameAstroglide Glycerin & Paraben Free Personal Lubricant
Version Model Number015594011776
Catalog NumberNA
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 Usetrue
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

Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 70 Degrees Celsius and 77 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Celsius and 77 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Celsius and 77 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Celsius and 77 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Celsius and 77 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Celsius and 77 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Celsius and 77 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Celsius and 77 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Celsius and 77 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Celsius and 77 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Celsius and 77 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Celsius and 77 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Celsius and 77 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Celsius and 77 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Celsius and 77 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Celsius and 77 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100015594011776 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-15
Device Publish Date2023-06-07

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