FDA.reportPublic FDA data

pjur AQUA Natural

Primary DI
10827160115439
Brand
pjur AQUA Natural
Company
Pjur Group Luxembourg SA
Model
pjur AQUA Natural, 100ml USA
Catalog number
13986-02
Device description
Water-based Personal Lubricant
Published
2022-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
10827160115439PackageGS112In Commercial Distribution
40827160115430PackageGS112In Commercial Distribution
00827160115432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082716011543910827160115439
4082716011543040827160115430
00827160115432008271601154328271601154320827160115432

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
400744553
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00827160112110pjur MAN Waterpjur MAN Water 100 ml - USA2018-12-04
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

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