U by Kotex

Basic Information

• Brand Name: U by Kotex
• Primary DI: 00036000464818
• Version / Model: Tampon
• Company Name: KIMBERLY-CLARK GLOBAL SALES, INC.
• Labeler DUNS: 829568273
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 15
• Record Status: Published
• Publish Date: 2019-03-26
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 6f092eee-d9c6-447c-bf83-b51abe9a505c
• Distribution End Date: 2021-07-01

Device Description

U BY KOTEX SUPER PREMIUM PLUS COMPACT FITNESS TAMPONS REGULAR ABSORBENCY

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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
HEB	TAMPON, MENSTRUAL, UNSCENTED	Obstetrics/Gynecology	884.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35694	Menstrual tampon, unscented	A non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual blood or other vaginal discharge. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10036000464815	GS1	Case	8	Not in Commercial Distribution	2021-07-01
Primary	00036000464818	GS1
Unit of Use	00036000999655	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Weight	9	Gram