FDA.reportPublic FDA data

Oh Yeah Water Based Lubricant

Primary DI
00850017860124
Brand
Oh Yeah Water Based Lubricant
Company
MANO & MANO PTY. LTD.
Model
8 fl oz (250ml)
Published
2020-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K161585000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161585000Mano and Mano Personal LubricantMano and Mano Proprietary Limited2016-09-06NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017860124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017860124008500178601248500178601240850017860124

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
749841222
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850017860155Nooky Water Based Lubricant 8 fl oz (250ml)2021-02-11
00850017860148Lulu Water Based Lubricant 8 fl oz (250ml)2020-10-02
00850017860001Nooky Lube Water Based Lubricant 16 fl oz (500ml)2020-06-01
00850017860018Nooky Lube Water Based Lubricant 32 fl oz ( 950ml)2020-06-01
00850017860025Lulu Water Based Lubricant 16 fl oz (500ml)2020-06-01
00850017860032Hello Sailor Water Based Lubricant 16 fl oz (500ml)2020-06-01
00850017860049Devotion Water Based Lubricant 16 fl oz (500ml)2020-06-01
00850017860056Love & Luster Water Based Lubricant 16 fl oz (500ml)2020-06-01
00850017860063BOOM Water Based Lubricant 8 fl oz (250ml)2020-06-01
00850017860070You Rock Water Based Lubricant 8 fl oz (250ml)2020-06-01
00850017860087ooh la la Water Based Lubricant 8 fl oz (250ml)2020-06-01
00850017860094Lulu Art Series Water Based Lubricant3 x 8 fl oz (250ml)2020-06-01
00850017860100Hot Stuff Water Based Lubricant 8 fl oz (250ml)2020-06-01
00850017860117Keep Going Water Based Lubricant 8 fl oz (250ml)2020-06-01
00850017860131Nooky Art Series Water Based Lubricant3 x 8 fl oz (250ml)2020-06-01

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