Screening Kit for Vaginal Health

Basic Information

• Brand Name: Screening Kit for Vaginal Health
• Primary DI: 17290006558074
• Version / Model: F-1-VO-WLG02
• Company Name: PEPTONIC MEDICAL ISRAEL LTD
• Labeler DUNS: 600850111
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2023-06-27
• Public Version: 1
• Public Version Date: 2023-07-05
• Public Version Status: New
• Public Device Record Key: 721c0b7b-6256-4fd8-bf73-14503e00fff8

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	862.1550	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54552	Vaginal pH screening IVD, kit, rapid colorimetric, clinical	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	17290006558074	GS1
Unit of Use	07290006558077	GS1