FDA.reportPublic FDA data

K-Y® Hydrablend

Primary DI
10067981993780
Brand
K-Y® Hydrablend
Company
RB Health (us) LLC
Model
00067981993783
Device description
1.5 oz. KY Hydrablend Hybrid Personal Lubricant
Published
2025-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K223519000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223519000Carex Hybrid Personal LubricantKarex Industries Sdn. Bhd.2023-08-11NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10067981993780PackageGS124In Commercial Distribution
00067981993783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1006798199378010067981993780
00067981993783000679819937830679819937830067981993783

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
081049410
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860016593107Cock Oil Water Based Lubricant Paraben Free 2 oz TubeCockOil LLCNUC2026-10-27
00860016593114Cock Oil Water Based Lubricant Paraben Free 7.5 oz Foil PacketCockOil LLCNUC2026-10-27
00860016593121Cock Oil Silicone Lubricant 9 oz Pump and Pour BottleCockOil LLCNUC2026-10-27
00884400733139JetlustFrisk LLCNUC2026-10-21
00726893119949One TrueGLOBAL PROTECTION CORP.NUC2026-10-07
00726893119956One TrueGLOBAL PROTECTION CORP.NUC2026-10-07
00726893119970One TrueGLOBAL PROTECTION CORP.NUC2026-10-07
20726893120123One TrueGLOBAL PROTECTION CORP.NUC2026-10-07
00860014736827King's Gear Water Based Lube 8 floz / 240 MLLSTX LLCNUC2026-10-01
00850012528593JUICY LIKE A PEACHJoylux, Inc.NUC2026-09-29
00796494750261LL 3x Anal 5mL Foils - 10pkCC Wellness LLCNUC2026-09-24
00796494750278LL Silky Silicone 5mL Foils - 10pkCC Wellness LLCNUC2026-09-24
08859798108670SKYNSURETEX LIMITED - BRANCHNUC2026-09-18
08859798108687SKYNSURETEX LIMITED - BRANCHNUC2026-09-18
08859798108694SKYNSURETEX LIMITED - BRANCHNUC2026-09-18
08859798108700SKYNSURETEX LIMITED - BRANCHNUC2026-09-18
08859798108717SKYNSURETEX LIMITED - BRANCHNUC2026-09-18
00199874950815Hyaluronic Acid Vaginal Suppository (HA 10 mg)HUDI PHARMA SRLNUC2026-09-06
00796494750216LL Water-Based 5mLCC Wellness LLCNUC2026-09-04
00796494750223LL Water-Based 5mL Foil - 10pkCC Wellness LLCNUC2026-09-04
00796494750230LL 3X Anal 5mLCC Wellness LLCNUC2026-09-04
00796494750247LL Silky Silicone 5mLCC Wellness LLCNUC2026-09-04
08721325867261SVibeAMOREO EUROPE SOCIEDAD LIMITADA.NUC2026-08-25
00651277000004Cock Oil Foil Packet water baseCockOil LLCNUC2026-08-24
00651277001681Cock Oil - Silicone 9ozCockOil LLCNUC2026-08-21
00651277069001Cock Oil - Natural Agape 2ozCockOil LLCNUC2026-08-21
06974586081637BEISAR, Water Solubility Human Body LubricantDongguan Yanxuan Biotechnology Co., Ltd.NUC2026-08-19
06979879080199RawTouchShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080205RawTouchShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080212RawTouchShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14