FDA.reportPublic FDA data

Meijer Vaginal Moisturizer Personal Lubricant

Primary DI
00708820514591
Brand
Meijer Vaginal Moisturizer Personal Lubricant
Company
MEIJER, INC.
Model
84010
Device description
Prefilled Disposable Personal Lubricant Applicator
Published
2020-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMJLubricant, Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMJLubricant, PatientGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K903910000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K903910000LUBRICATING JELLYLake Pharmaceutical, Inc.1990-10-26KMJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00708820514591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00708820514591007088205145917088205145910708820514591

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

Contacts#

Phone, Email table
PhoneEmail
262-677-7131mwundrock@pharmacalway.com

Regulatory Flags#

DUNS number
006959555
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00713733712835MeijerMJ4035V130522902026-06-05
00719283515964meijer71928351596443238042019-07-30
00713733293129MEIJERMJFAK150V2MJFAK150V22026-04-20
00760236195603MeijerMJFAKMINIMJFAKMINI2026-04-20
00760236195771Meijer20002290N/A2026-04-01
00760236195818Meijer20002291N/A2026-04-01
00760236264811Meijer Advanced One Step Pregnancy Test2020-10-02
00760236264828Meijer Advanced Early Result Pregnancy Test2020-10-02
00760236471646Meijer Saline Wound Wash 95-50740-200-002026-03-06
00719283501233Meijer74-9713487072020-12-07
00719283501288Meijer74-9732020-12-07
00719283338334Meijer Hot & Cold Compression Migraine Mask7192833383342024-04-03
00708820957367Meijer, instant cold pack, value pack 36501102021-02-04
00708820957473Meijer, instant cold pack 36501092020-07-21
00708820519541Meijer Hot/Cold Back Pad34572442017-08-01
00708820519558Meijer Hot & Cold Wrap Ultra-Forming 34572462017-08-01
00708820523418Meijer Hot & Cold Therapy Wrap with Clay Based Technology34583982017-08-01
00708820523425Meijer Hot & Cold Beads Compress with Strap34583972017-08-01
00708820523432Meijer Moist Heat Neck Wrap34583962017-08-01
00760236195696Meijer57005082025-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08887500730017SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
08887500730024SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
08887500730031SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
00627987071429NixitMAYER LABORATORIES, INC.KMJ2025-09-16
06936603230992Medical LubricantYangzhou Fartley Medical Instrument Technology Co., LtdKMJ2025-06-23
16936603230999Medical LubricantYangzhou Fartley Medical Instrument Technology Co., LtdKMJ2025-06-23
30080196074192MEDLINEMEDLINE INDUSTRIES, INC.KMJ2025-04-25
40080196074199MEDLINEMEDLINE INDUSTRIES, INC.KMJ2025-04-25
17290100666156Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2025-04-02
00858276007557Sterile Bacteriostatic Lubricating GelMicro-tech UsaKMJ2025-03-05
00850025860482Endoscopy Kit - Basic + GownsMicro-tech UsaKMJ2025-03-04
10850025860489Endoscopy Kit - Basic + GownsMicro-tech UsaKMJ2025-03-04
00850025860062Endoscopy Kit - Basic+Micro-tech UsaKMJ2025-03-03
00850025860215Endoscopy Kit - Compliance+Micro-tech UsaKMJ2025-03-03
00850025860277Endoscopy Kit - ComplianceMicro-tech UsaKMJ2025-03-03
00858276007434Endoscopy Kit - BasicMicro-tech UsaKMJ2025-03-03
00858276007465Endoscopy Kit - UpperMicro-tech UsaKMJ2025-03-03
00858276007496Endoscopy Kit - Set UpMicro-tech UsaKMJ2025-03-03
00850025860079Endoscopy Kit - Basic+Micro-tech UsaKMJ2025-03-03
00850025860222Endoscopy Kit - Compliance+Micro-tech UsaKMJ2025-03-03
00850025860284Endoscopy Kit - ComplianceMicro-tech UsaKMJ2025-03-03
00858276007441Endoscopy Kit - BasicMicro-tech UsaKMJ2025-03-03
00858276007472Endoscopy Kit - UpperMicro-tech UsaKMJ2025-03-03
00858276007502Endoscopy Kit - Set UpMicro-tech UsaKMJ2025-03-03
00850041319001EsoCoolNuvaira, Inc.KMJ2025-01-29
00850041319018EsoCoolNuvaira, Inc.KMJ2025-01-29
00850058254623EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16
00850058254630EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16
00850058254647EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16
00850058254654EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16