VS-SENSE

GUDID 07290006558169

PEPTONIC MEDICAL ISRAEL LTD

Vaginal pH screening IVD, kit, rapid colorimetric, clinical Vaginal pH screening IVD, kit, rapid colorimetric, clinical Vaginal pH screening IVD, kit, rapid colorimetric, clinical Vaginal pH screening IVD, kit, rapid colorimetric, clinical Vaginal pH screening IVD, kit, rapid colorimetric, clinical Vaginal pH screening IVD, kit, rapid colorimetric, clinical Vaginal pH screening IVD, kit, rapid colorimetric, clinical Vaginal pH screening IVD, kit, rapid colorimetric, clinical Vaginal pH screening IVD, kit, rapid colorimetric, clinical Vaginal pH screening IVD, kit, rapid colorimetric, clinical Vaginal pH screening IVD, kit, rapid colorimetric, clinical Vaginal pH screening IVD, kit, rapid colorimetric, clinical Vaginal pH screening IVD, kit, rapid colorimetric, clinical Vaginal pH screening IVD, kit, rapid colorimetric, clinical Vaginal pH screening IVD, kit, rapid colorimetric, clinical

• Primary Device ID: 07290006558169
• NIH Device Record Key: 51d78538-2afd-4fab-991d-2fc26c34fb59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VS-SENSE
• Version Model Number: F-VS-HS2
• Company DUNS: 600850111
• Company Name: PEPTONIC MEDICAL ISRAEL LTD
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290006558169 [Unit of Use]
GS1	17290006558166 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091287

FDA Product Code

• CEN: Dye-Indicator, Ph (Urinary, Non-Quantitative)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-06
• Device Publish Date: 2023-06-28

Devices Manufactured by PEPTONIC MEDICAL ISRAEL LTD

• 07290006558091 - VagiVital VS: 2023-07-06
• 07290006558107 - Vagi-Screen Vaginal Health Test: 2023-07-06
• 07290006558114 - Florisense Vaginal Health Test: 2023-07-06
• 07290006558121 - Florisense Preconception Vaginal Health Test: 2023-07-06
• 07290006558138 - Feminine Screening Kit: 2023-07-06
• 07290006558145 - Equate: 2023-07-06
• 07290006558152 - Clinistix Vaginal Health Test: 2023-07-06
• 07290006558169 - VS-SENSE: 2023-07-06
• 07290006558169 - VS-SENSE: 2023-07-06