U by Kotex

Basic Information

• Brand Name: U by Kotex
• Primary DI: 00036000476033
• Version / Model: Pad
• Company Name: KIMBERLY-CLARK GLOBAL SALES, INC.
• Labeler DUNS: 829568273
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 90
• Record Status: Published
• Publish Date: 2018-01-10
• Public Version: 7
• Public Version Date: 2022-09-30
• Public Version Status: Update
• Public Device Record Key: 9023e1c0-61d2-4adf-bbc0-5e1bf19b37f0
• Distribution End Date: 2022-09-30

Device Description

U BY KOTEX SUPER PREM BARELY THERE LONG FOLDED AND WRAPPED PANTILINERS 90

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: Yes
• 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
HHD	Pad, menstrual, unscented	Obstetrics/Gynecology	884.5435	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40545	Menstrual pad, unscented	A non-deodorized, feminine hygiene product (a pad) that is held in place externally to absorb menstrual 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
Primary	00036000476033	GS1
Unit of Use	00036000536744	GS1
Package	10036000476030	GS1	Case	5	Not in Commercial Distribution	2022-09-30

Customer Contacts

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