FDA.reportPublic FDA data

FLIP Lube

Primary DI
00853517007013
Brand
FLIP Lube
Company
LUBRINOVATION, INC.
Model
1
Device description
4 oz. bottle of FLIP Lube personal lubricant
Published
2019-01-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K171516000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171516000Flip LubeImquest Biosciences, Inc.2018-02-05NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853517007013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853517007013008535170070138535170070130853517007013

GMDN Terms#

Term, Definition table
TermDefinition
Sexual lubricantA non-sterile 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. It is normally available [non-prescription] over-the-counter (OTC). After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature55 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(240) 397-5051info@fliplube.com

Regulatory Flags#

DUNS number
116835739
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853517007020FLIP Lube12019-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00796494750278LL Silky Silicone 5mL Foils - 10pkCC Wellness LLCNUC2026-09-24
08859798108670skynSURETEX LIMITED - BRANCHNUC2026-09-18
08859798108687SKYNSURETEX LIMITED - BRANCHNUC2026-09-18
08859798108694SKYNSURETEX LIMITED - BRANCHNUC2026-09-18
08859798108700SKYNSURETEX LIMITED - BRANCHNUC2026-09-18
08859798108717SKYNSURETEX LIMITED - BRANCHNUC2026-09-18
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00796494750216LL Water-Based 5mLCC Wellness LLCNUC2026-09-04
00796494750223LL Water-Based 5mL Foil - 10pkCC Wellness LLCNUC2026-09-04
00796494750230LL 3X Anal 5mLCC Wellness LLCNUC2026-09-04
00796494750247LL Silky Silicone 5mLCC Wellness LLCNUC2026-09-04
08721325867261SVibeAMOREO EUROPE SOCIEDAD LIMITADA.NUC2026-08-25
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