AccessGUDID - DEVICE: U by Kotex (00036000030280)

GUDID

Device Identifier (DI) Information

Brand Name: U by Kotex
Version or Model: Pad
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: KIMBERLY-CLARK GLOBAL SALES, INC.

Primary DI Number: 00036000030280
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2022
Device Count: 44
Labeler D-U-N-S® Number*: 829568273 *Terms of Use

Device Description: U BY KOTEX PREMIUM LONG SUPER MAXI PADS BIGPAK 44

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HHD	Pad, menstrual, unscented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b6b32116-e04b-4087-9371-2a3b88872ab9
Public Version Date: September 30, 2022
Public Version Number: 3
DI Record Publish Date: July 01, 2020