FDA.reportPublic FDA data

VS-SENSE

Primary DI
07290006558169
Brand
VS-SENSE
Company
PEPTONIC MEDICAL ISRAEL LTD
Model
F-VS-HS2
Published
2023-06-28
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
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
17290006558166PrimaryGS10
07290006558169Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729000655816617290006558166
07290006558169072900065581697290006558169

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600850111
Device count
25
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
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
17290006558180Monistat ProF-1-VS-MON252023-06-28
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
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
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.CEN2026-06-03
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