FDA.reportPublic FDA data

KY Liquid Lubricant

Primary DI
88067981087084
Brand
KY Liquid Lubricant
Company
RB Health (us) LLC
Model
Personal Lubricant
Device description
Personal Lubricant
Published
2016-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HISCONDOM
NUCLubricant, Personal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2
NUCLubricant, PersonalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193032000
K955648000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193032000KY Grosz LiquidRb Health (Us), LLC2020-04-20NUC
K955648000K-Y PERSONAL LUBRICANTOrtho Pharmaceutical Corp.1996-06-21HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10067981087083PackageGS14Not in Commercial Distribution
20067981087080PackageGS16Not in Commercial Distribution
88067981087084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1006798108708310067981087083
2006798108708020067981087080
8806798108708488067981087084

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place away from direct sunlight

Contacts#

Phone, Email table
PhoneEmail
+1(800)756-5488xxx@xxx.xxx

Regulatory Flags#

DUNS number
081049410
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50302340996131Durex Intense003023409961362026-03-02
00067981087956KY Personal Lubricant Jelly000679810890282025-12-09
00067981087963KY Personal Lubricant Jelly000679810891272025-12-09
10067981088059KY Warming Jelly 000679810894792025-12-09
10067981088042KY Warming Jelly 000679810894862025-12-09
10067981993698KY Personal Lubricant Jelly000679819936912025-12-09
10067981993964KY Natural Feeling with Hyaluronic Acid000679819939672025-12-09
10067981993971KY Natural Feeling with Hyaluronic Acid000679819939742025-12-09
10067981993988KY Natural Feeling with Aloe Vera Lubricant000679819939812025-12-09
00067981087253KY Intense CondomsCondom2019-05-30
00067981087260KY Intense CondomsCondom2019-05-30
00067981087277KY Intense CondomsCondom2019-10-14
00067981087758KY Extra Lubricated CondomsCondom2019-06-12
00067981087765KY Intense CondomsCondom2019-06-12
00067981941845KY Touch 2-in-1 Massage Creme & Pleasure GelPersonal Lubricant2016-09-20
00067981962161KY Touch 2-in-1 Massage Creme & Pleasure GelPersonal Lubricant2016-09-20
00067981087925KY UltraGel Personal Lubricant000679810873522016-09-20
00067981087932KY UltraGel Personal Lubricant000679810873762016-09-20
00067981963038KY Natural Feeling with Botanical Essence Lubricant & Massage GelPersonal Lubricant2018-10-31
00067981087178KY Extra Lubricated CondomsCondom2018-10-31

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Primary DI, Brand, Company table
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00796494750247LL Silky Silicone 5mLCC Wellness LLCNUC2026-09-04
06977708239688ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239695ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
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06977708239718ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239725ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239732ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
08721325867261SVibeAMOREO EUROPE SOCIEDAD LIMITADA.NUC2026-08-25
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00860014891533HUNKHunk World, Inc.HIS2026-08-19
00860014891540HUNKHunk World, Inc.HIS2026-08-19
00860014891557HUNKHunk World, Inc.HIS2026-08-19
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