FDA.reportPublic FDA data

Astroglide Gel Personal Lubricant

Primary DI
00015594010106
Brand
Astroglide Gel Personal Lubricant
Company
BIOFILM, INC
Model
015594010106
Device description
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.
Published
2017-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUCLubricant, Personal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUCLubricant, PersonalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003867000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003867000EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)Biofilm, Inc.2001-03-09NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00015594010106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00015594010106000155940101060155940101060015594010106

GMDN Terms#

Term, Definition table
TermDefinition
Sexual lubricantA substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight113Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature70 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-848-5900customer.service@biofilm.com

Regulatory Flags#

DUNS number
790780258
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00015594000015Astroglide Sensual Strawberry Personal Lubricant015594000015N/A2025-07-05
00015594000046Astroglide X Silicone Liquid015594000046N/A2025-07-05
00015594012148Astroglide Gel Personal Lubricant0155940121482024-08-21
00015594012094Astroglide X Silicone Liquid0155940120942023-08-29
00015594011653Astroglide Organix Liquid015594011653N/A2023-06-10
00015594011813Astroglide Ultra Gentle Gel015594011813N/A2023-06-10
00015594011837Astroglide X Silicone Liquid015594011837N/A2023-06-10
00015594011929Astroglide Toy 'N Joy Personal Lubricant0155940119292023-06-10
00015594011769Astroglide X Premium Silicone Gel Personal Lubricant0155940117692023-06-07
00015594011776Astroglide Glycerin & Paraben Free Personal Lubricant015594011776NA2023-06-07
00015594011844Astroglide O Oil Massage Oil & Personal Lubricant015594011844N/A2023-06-07
00015594011851Astroglide Gel Personal Lubricant015594011851N/A2023-06-07
00015594012056Astroglide Sensual Strawberry Personal Lubricant0155940120562023-06-07
00015594011035Astroglide Ultra Gentle Gel015594011035N/A2023-06-06
00015594010632Astroglide Glycerin & Paraben Free0155940106322022-02-15
00015594011882Astroglide Toy N Joy0155940118822022-02-15
00015594011967Astroglide Quiver0155940119672022-02-15
00015594010342Astroglide Warming Liquid Personal Lubricant0155940103422016-09-13
00015594010540Astroglide Sensual Strawberry Personal Lubricant0155940105402016-09-13
00015594010861Astroglide X Silicone Liquid0155940108612022-02-15

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