FDA.reportPublic FDA data

Equaline

Primary DI
00041163250925
Brand
Equaline
Company
SUPERVALU INC.
Model
7W926ELC2
Device description
Personal Lubricant4oz. (113g)
Published
2022-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
K180923000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180923000Personal Lubricating JellyPerrigo New York, Inc.2018-07-09NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10041163250922PackageGS172In Commercial Distribution
00041163250925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004116325092210041163250922
00041163250925000411632509250411632509250041163250925

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal lubricantA non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
006961411
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00041163500648Equaline0411635006482020-05-29
00041163498174EqualineALB4145ALB41452025-10-09
00041163503885EqualineKD-20502023-09-05
20041163503889EqualineKD-20502023-09-05
10041163250922Equaline7W926ELC22022-10-11
00041163263352Equaline TamponsBSVAR402016-09-20
00041163263369Equaline TamponsBSVAS402016-09-20
00041163263383Equaline TamponsBSVAC402016-09-20
00041163444164Equaline TamponsBSVGC362016-09-20
00041163471559Equaline TamponsBSVGS182016-09-20
00041163497306Equaline TamponsBSVUR182016-09-20
00041163497313Equaline TamponsBSVUS182016-09-20
00041163497344Equaline TamponsBSVGS362016-09-20
00041163497368Equaline TamponsBSVGR362016-09-20
00041163497375Equaline TamponsBSVGR182016-09-20
00041163499133Equaline TamponsBSVXR182017-05-02
00041163499140Equaline TamponsBSVXS182017-05-02
00041163499157Equaline TamponsBSVXC182017-05-02
00041163450240Equaline0411634502402020-05-29
00041163450257Equaline0411634502572020-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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 JellyRB Health (us) LLCNUC2025-12-09
00067981089486KY Warming Jelly RB Health (us) LLCNUC2025-12-09
00067981952292KY Intense Pleasure GelRB Health (us) LLCNUC2025-12-09
00067981993691KY Personal Lubricant JellyRB Health (us) LLCNUC2025-12-09
00067981993738KY Personal Lubricant JellyRB Health (us) LLCNUC2025-12-09
00067981993967KY Natural Feeling with Hyaluronic AcidRB Health (us) LLCNUC2025-12-09
00067981993974KY Natural Feeling with Hyaluronic AcidRB Health (us) LLCNUC2025-12-09
00067981993981KY Natural Feeling with Aloe Vera LubricantRB Health (us) LLCNUC2025-12-09
30726893210043One MoveGLOBAL PROTECTION CORP.NUC2025-11-13
00016169700057Nauox Yin YangMAYER LABORATORIES, INC.NUC2025-10-06
00016169700064Nauox Holy HoneyMAYER LABORATORIES, INC.NUC2025-10-06
00016169700071Nauox Dulce DreamsMAYER LABORATORIES, INC.NUC2025-10-06
00016169700088Nauox Sweet HavenMAYER LABORATORIES, INC.NUC2025-10-06
00016169700095Naoux Agave NectarMAYER LABORATORIES, INC.NUC2025-10-06
00016169700194Femme GlydeMAYER LABORATORIES, INC.NUC2025-10-06
00198715811087Kindra V LubeMAYER LABORATORIES, INC.NUC2025-10-06
07964944077692LubeLife - Water-based 8oz - Retail - 3pkCC Wellness LLCNUC2025-07-22
07964944078996LubeLife - Strawberry 8oz - Retail - 3pkCC Wellness LLCNUC2025-07-22
00067981993783K-Y® Hydrablend RB Health (us) LLCNUC2025-07-10
08032595872429REVAREEFARMA DERMA SRLNUC2025-06-26
08032595872436REVAREEFARMA DERMA SRLNUC2025-06-26
08859798106058LIFESTYLESSURETEX LIMITED - BRANCHNUC2025-06-18
00067981994155KY Warming Liquid LubricantRB Health (us) LLCNUC2025-06-01
00067981994162KY Yours & Mine Couples LubricantRB Health (us) LLCNUC2025-06-01