FDA.reportPublic FDA data

Monistat Pro

Primary DI
17290006558180
Brand
Monistat Pro
Company
PEPTONIC MEDICAL ISRAEL LTD
Model
F-1-VS-MON25
Published
2023-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CENDye-Indicator, Ph (Urinary, Non-Quantitative)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CENDye-Indicator, Ph (Urinary, Non-Quantitative)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091287000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091287000VS-SENSE TESTCommon Sense , Ltd.2009-08-31CEN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290006558180PrimaryGS10
07290006558183Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729000655818017290006558180
07290006558183072900065581837290006558183

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal pH screening IVD, kit, rapid colorimetric, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative determination of the pH range of vaginal secretionse within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Regulatory Flags#

DUNS number
600850111
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290006558098VagiVital VSF-1-VO-VVUS-022023-06-28
17290006558104Vagi-Screen Vaginal Health TestF-1-VO-VASC-022023-06-28
17290006558111Florisense Vaginal Health TestF-1-VO-AMZU22023-06-28
17290006558128Florisense Preconception Vaginal Health TestF-1-VO-FLPR2023-06-28
17290006558135Feminine Screening KitF-1-VO-CVS022023-06-28
17290006558142EquateF-1-VO-WAL022023-06-28
17290006558159Clinistix Vaginal Health TestF-1-VO-CLSM022023-06-28
17290006558166VS-SENSEF-VS-HS22023-06-28
17290006558173NuvetestF-1-VS-EX2023-06-28
07290006558091VagiVital VSF-1-VO-VVUS-022023-06-28
07290006558107Vagi-Screen Vaginal Health TestF-1-VO-VASC-022023-06-28
07290006558114Florisense Vaginal Health TestF-1-VO-AMZU22023-06-28
07290006558121Florisense Preconception Vaginal Health TestF-1-VO-FLPR2023-06-28
07290006558138Feminine Screening KitF-1-VO-CVS022023-06-28
07290006558145EquateF-1-VO-WAL022023-06-28
07290006558152Clinistix Vaginal Health TestF-1-VO-CLSM022023-06-28
07290006558169VS-SENSEF-VS-HS22023-06-28
07290006558176NuvetestF-1-VS-EX2023-06-28
07290006558183Monistat ProF-1-VS-MON252023-06-28
17290006558081VS-SENSE OTCF-1-VOCS-022023-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16936983131695Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-16
16936983141120Discover Multi-Drug 12 Drugs Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-16
16936983141137Discover Multi-Drug 12 Drugs Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-16
16936983144770Discover Multi-Drug 9 Drugs Rapid Test Cup (Urine) Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-16
16936983148846Discover Multi-Drug 12 Drugs Rapid Test Cup (Urine) Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-16
16936983153819Discover Multi-Drug 13 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-15
16936983165379Discover Multi-Drug 5 Drugs Rapid Test Cup(Urine) Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-15
16936983169605Alltest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.CEN2026-04-15
16936983169865Discover Multi-Drug 6 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-15
16936983169872Discover Multi-Drug 8 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-15
16936983170038Alltest Multi-Drug 14 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.CEN2026-04-15
16936983172414Alltest Multi-Drug 13 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983180600Alltest Multi-Drug 13 Drugs Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983180617Alltest Multi-Drug 14 Drugs Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983181270Alltest Multi-Drug 9 Drugs Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983186077Alltest Multi-Drug 14 Drugs Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983186893DrugTect Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187074Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187081Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187098Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187104Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187135Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187142Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187159Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187166Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187173Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187180Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187203Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187210Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16942598222673Alltest Multi-Drug 18 Drugs Urine Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14