FDA.reportPublic FDA data

Signature Care

Primary DI
20321130780247
Brand
Signature Care
Company
BETTER LIVING BRANDS LLC
Model
7W926LJC3
Device description
Personal Lubricating Jelly 4oz. (113g)
Published
2022-10-11
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
20321130780247PackageGS16In Commercial Distribution
30321130780244PackageGS172In Commercial Distribution
00321130780243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2032113078024720321130780247
3032113078024430321130780244
00321130780243003211307802433211307802430321130780243

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
080349866
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
00321130762843Signature Care3211307628432020-08-10
00321130762850Signature Care3211307628502020-08-10
00321130788812Signature Care3211307888122020-07-31
00321130144724Signature Care3211301447242020-07-31
00321130078210Signature Care3211300782102020-07-31
00321130211419Signature Select3211302114192025-10-02
00321130211426Signature Select3211302114262025-10-02
00021130163830Signature Care Digital Pregnancy Test2021-04-16
00321130352945Signature SelectOne Step Pregnancy TestN/A2025-02-27
00021130163823Signature Care One Step Pregnancy Test2021-04-16
00321130195900Signature Care321130195900X004JE7MZP2022-12-12
00321130351115AlbertsonsDigital Wide-Tip Pregnancy TestN/A2025-03-03
10321130351112AlbertsonsDigital Wide-Tip Pregnancy TestN/A2025-03-03
10321130352942Signature SelectOne Step Pregnancy TestN/A2025-02-27
00021130790005Signature Care Early Result Pregnancy Test2016-10-26
00321130195894Signature Care3211301958942022-12-12
10321130195891Signature Care3211301958942022-12-12
10321130195907Signature Care3211301959002022-12-12
00321130780595Safeway Facemask SAF384RSAF384R2016-09-24
00021130790050Signature Care Digital Pregnancy Test2016-10-26

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 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
07964944077692LubeLife - Water-based 8oz - Retail - 3pkCC Wellness LLCNUC2025-07-22
07964944078996LubeLife - Strawberry 8oz - Retail - 3pkCC Wellness LLCNUC2025-07-22