FDA.reportPublic FDA data

Kroger

Primary DI
20041260332252
Brand
Kroger
Company
KROGER CO., THE
Model
7W92645C2
Device description
Lubricating Jelly 4oz (113g)
Published
2022-09-23
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
false

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
K012203000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012203000CLAY-PARK LABS, INC. - LUBRICATING JELLYClay-Park Labs, Inc.2001-08-27NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10041260332255PackageGS172In Commercial Distribution
20041260332252PackageGS16In Commercial Distribution
00011110384492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004126033225510041260332255
2004126033225220041260332252
00011110384492000111103844920111103844920011110384492

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006999528
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00041260025747Kroger04126002574763610912025-08-05
00041260011658Kroger PJ Masks0412600116582021-01-13
00041260017957Kroger0412600179572023-01-31
00041260017964Kroger0412600179642023-01-31
00041260377501Kroger0412603775012020-08-17
00041260377518Kroger0412603775182019-10-30
00041260383809Kroger0412603838092020-06-22
00041260383816Kroger0412603838162020-06-22
00041260026850Kroger0412600268502026-03-09
60041260026852Kroger0412600268502026-03-09
60041260025749Kroger04126002574763610912025-08-05
10041260346962Kroger Blood Glucose Test Strips8000-042412016-09-24
10041260346979Kroger Blood Glucose Test Strips8000-042412016-09-24
10041260360685Kroger Premium Blood Glucose Meter8000-067682016-09-24
10041260360692Kroger Premium Blood Glucose Test Strips8000-067622016-09-24
00011110338235Kroger Pen Needles7000013332016-09-24
00041260003592Kroger Pen Needles7000147202019-06-01
00041260003608Kroger Pen Needles7000147212019-06-01
00041260343469Kroger Pen Needles7000013322016-09-24
00041260364624Kroger Pen Needles7000013312016-09-24

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
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