FDA.reportPublic FDA data

Pink

Primary DI
00813362024139
Brand
Pink
Company
Empowered Products, Inc.
Model
Silicone - 4oz
Device description
4oz glass bottle of silicone based lubricant intended for use during intercourse or masturbation.
Published
2022-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K152918000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152918000Gun Oil, Pink, Gun Oil H2O, Pink WaterEmpowered Products, Inc.2016-06-02NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20891306000092PackageGS18In Commercial Distribution
00813362024139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2089130600009220891306000092
00813362024139008133620241398133620241390813362024139

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.

Contacts#

Phone, Email table
PhoneEmail
(702) 216-1321helpdesk@empoweredproducts.com

Regulatory Flags#

DUNS number
784316213
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813362024146PinkWater - 4oz2022-02-09
00891306000074Gun OilSilicone - 8oz2022-02-09
00891306000166PinkSilicone - Sample2022-02-09
00891306000173Gun OilH2O - 2oz2022-02-09
00891306000180Gun OilH2O - 4oz2022-02-09
00891306000197Gun OilH2O - 8oz2022-02-09
00891306000203Gun OilH2O - Sample2022-02-09
00891306000210Gun OilSilicone - Sample2022-02-09
00891306000227Gun OilSilicone - 16oz2022-02-09
00891306000234Gun OilH2O - 16oz2022-02-09
00891306000296Gun OilSilicone - 32oz2022-02-09
00891306000302Gun OilH2O - 32oz2022-02-09
00891306000418PinkWater - 4.7oz2022-02-09
00891306000456PinkSilicone - 2.8oz2022-02-09
00891306000463PinkWater - 2.8oz2022-02-09
00891306000661PinkWater - Sample2022-02-09
00891306000968PinkWater - 8oz2022-02-09
20891306000092PinkSilicone - 4oz2022-02-09
10891306000903PinkWater - 4oz2022-02-09
00891306000036Gun OilSilicone - 2oz2022-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20726893120482Mixed PleasureGLOBAL PROTECTION CORP.NUC2026-06-04
00796494006160Williams-Trading/Cloud 9 Water-Based 4ozCC Wellness LLCNUC2026-06-02
00796494006177Williams-Trading/Cloud 9 Water-Based 8ozCC Wellness LLCNUC2026-06-02
00796494006184Williams-Trading/Cloud 9 Cum Lubricant 8ozCC Wellness LLCNUC2026-06-02
00796494404089JO Cumplay 4ozCC Wellness LLCNUC2026-06-02
00087701190797good neighbor pharmacyAmerisourcebergen Drug CorporationNUC2026-06-01
00787651760643AZOi-Health, Inc.NUC2026-05-29
00796494455043LL Water-Based Gallon LubricantCC Wellness LLCNUC2026-05-28
08887500730017SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08887500730024SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08887500730031SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08859798108090LIFESTYLESSURETEX LIMITED - BRANCHNUC2026-01-27
20011509061328VagisilCombe IncorporatedNUC2026-01-26
00067981089127KY Personal Lubricant JellyRECKITT BENCKISER LLCNUC2025-12-09
00067981089486KY Warming JellyRECKITT BENCKISER LLCNUC2025-12-09
00067981952292KY Intense Pleasure GelRECKITT BENCKISER LLCNUC2025-12-09
00067981993691KY Personal Lubricant JellyRECKITT BENCKISER LLCNUC2025-12-09
00067981993738KY Personal Lubricant JellyRECKITT BENCKISER LLCNUC2025-12-09
00067981993967KY Natural Feeling with Hyaluronic AcidRECKITT BENCKISER LLCNUC2025-12-09
00067981993974KY Natural Feeling with Hyaluronic AcidRECKITT BENCKISER LLCNUC2025-12-09
00067981993981KY Natural Feeling with Aloe Vera LubricantRECKITT BENCKISER LLCNUC2025-12-09
00067981089479KY Warming JellyRECKITT BENCKISER LLCNUC2025-12-09
00067981089028KY Personal Lubricant JellyRECKITT BENCKISER LLCNUC2025-12-09
30726893210043One MoveGLOBAL PROTECTION CORP.NUC2025-11-13
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