Astroglide Ultra Gentle Gel N/A

GUDID 00015594011035

Astroglide Ultra Gentle Gel 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 compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

BIOFILM, INC

Sexual lubricant
Primary Device ID00015594011035
NIH Device Record Key49b6f5f3-3942-4581-acde-6c1f3f906af6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAstroglide Ultra Gentle Gel
Version Model Number015594011035
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
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
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
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
GS100015594011035 [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 Date2023-06-14
Device Publish Date2023-06-06

On-Brand Devices [Astroglide Ultra Gentle Gel]

00015594011035Astroglide Ultra Gentle Gel is a personal lubricant for penile, vaginal, and/or anal applicatio
00015594011813Astroglide Ultra Gentle Gel is a personal lubricant for penile, vaginal, and/or anal applicatio

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