U by Kotex

Basic Information

• Brand Name: U by Kotex
• Primary DI: 00036000423396
• Version / Model: Tampon
• Company Name: KIMBERLY-CLARK GLOBAL SALES, INC.
• Labeler DUNS: 829568273
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 34
• Record Status: Published
• Publish Date: 2019-04-02
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 88ec9afa-6732-48f4-af1e-6cc130cef872
• Distribution End Date: 2021-09-30

Device Description

U BY KOTEX PREMIUM SECURITY SUPER PLUS TAMPONS

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	00036000483505	GS1	Case	4	Not in Commercial Distribution	2021-09-30
Primary	00036000423396	GS1
Package	10036000423393	GS1	Case	6	Not in Commercial Distribution	2019-04-02
Package	00036000442052	GS1	Case	3	Not in Commercial Distribution	2021-09-30
Unit of Use	00036000998443	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141294	000

Device Sizes

Type	Value	Unit	Text
Weight	15	Gram