FDA.reportPublic FDA data

Astroglide Organix Liquid

Primary DI
00015594011653
Brand
Astroglide Organix Liquid
Company
BIOFILM, INC
Model
015594011653
Catalog number
N/A
Device description
Astroglide® Organix Liquid Personal Lubricant is non-sterile, colorless to slight yellow, 95% organic and water-based personal lubricant. The glycerin and botanicals are certified USDA organic, helping to contribute to an NSF/ANSI 305 certified final product. This product is not a spermicide or contraceptive. Organix Liquid is compatible with natural rubber latex condoms. Organix Liquid is not compatible with polyurethane, or polyisoprene condoms.
Published
2023-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
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
K200114000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200114000Astroglide Organix LiquidBiofilm, Inc.2020-10-13NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00015594011653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00015594011653000155940116530155940116530015594011653

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
Total Volume2.5Milliliter

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
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
00015594011639Astroglide Organix Liquid0155940116392022-02-15

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Primary DI, Brand, Company table
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