Gynex

Basic Information

• Brand Name: Gynex
• Primary DI: GYNXPH991
• Version / Model: PH-99
• Company Name: GYNEX CORPORATION
• Labeler DUNS: 012997685
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2023-12-20
• Public Version: 1
• Public Version Date: 2023-12-28
• Public Version Status: New
• Public Device Record Key: 15c1d55a-3b98-4315-a7d9-ae9d1e161dd0

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LNW	Paper, Obstetric Ph	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
Unit of Use	GYNXPH990	HIBCC
Primary	GYNXPH991	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K032161	000