FDA.reportPublic FDA data

pjur MAN Water

Primary DI
00827160112110
Brand
pjur MAN Water
Company
Pjur Group Luxembourg SA
Model
pjur MAN Water 100 ml - USA
Device description
Water-based Personal Lubricant
Published
2018-12-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
K010199000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010199000PJUR EROS WATER FORMULATIONL.C.C. Pjur Group Germany2001-04-05NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827160112117PackageGS112Not in Commercial Distribution
40827160112118PackageGS112Not in Commercial Distribution
00827160112110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082716011211710827160112117
4082716011211840827160112118
00827160112110008271601121108271601121100827160112110

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.

Regulatory Flags#

DUNS number
400744553
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827160117436pjur NATURE Touchpjur NATURE Touch 100 ml - USA14118-022026-07-03
00827160117238pjur TOY GLIDEpjur TOY GLIDE 5 ml - USA14098-022026-04-21
00827160116866pjur TOY GLIDEpjur TOY GLIDE 100 ml - USA14070-022025-05-23
00827160115012pjur ORIGINAL Sachetcard 2021, 1,5ml USApjur ORIGINAL Sachetcard 2021, 1,5ml USA2021-07-23
40827160116864pjur TOY GLIDEpjur TOY GLIDE 100 ml - USA14070-022025-05-23
00827160116774pjur BACK DOOR Relaxingpjur BACK DOOR Relaxing 30ml - USA14062-022025-04-16
00827160116781pjur BACK DOOR Moisturizingpjur BACK DOOR Moisturizing 30ml - USA14063-022025-04-16
00827160116750pjur analyse me! Relaxing, 1,5 ml USApjur analyse me! Relaxing, 1,5ml USA (50 pcs)14060-022025-04-16
10827160116771pjur BACK DOOR Relaxingpjur BACK DOOR Relaxing 30ml - USA14062-022025-04-16
10827160116788pjur BACK DOOR Moisturizingpjur BACK DOOR Moisturizing 30ml - USA14063-022025-04-16
00827160114350pjur analyse me! Moisturizing glidepjur analyse me! Moisturizing 10 ml - USA (50 pcs.13780-02 2025-04-10
00827160116767pjur AQUA Nakedpjur AQUA Naked, 30ml USA14061-022025-03-24
10827160116764pjur AQUA Nakedpjur AQUA Naked, 30ml USA14061-022025-03-24
00827160114367pjur WOMAN Nudepjur WOMAN Nude 10 ml - USA13790-02 2024-05-23
00827160116279pjur med HYDROpjur med HYDRO 2 ml - USA 14026-022024-04-30
00827160116286pjur med SENSITIVEpjur med SENSITIVE 2ml - USA 14027-022024-04-30
00827160116293pjur AQUA Naturalpjur AQUA Natural 2ml - USA14028-022024-04-30
10827160116276pjur med HYDROpjur med HYDRO 2 ml - USA 14026-022024-04-30
10827160116283pjur med SENSITIVEpjur med SENSITIVE 2ml - USA 14027-022024-04-30
10827160116290pjur AQUA Naturalpjur AQUA Natural 2ml - USA14028-022024-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199284921726Urge Silicone Personal LubricantUrge Cream LLCNUC2026-07-08
00827160117436pjur NATURE TouchPjur Group Luxembourg SANUC2026-07-03
06979879080236ArousellubeShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080250ArousellubeShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080267ArousellubeShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080298Oye JoyShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080304Oye JoyShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080311TantalyShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080328TantalyShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080342SyronosShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
00796494006191Kindra - Water-based Lubricant - 3.4ozCC Wellness LLCNUC2026-06-10
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