FDA.reportPublic FDA data

U by Kotex

Primary DI
00036000538038
Brand
U by Kotex
Company
KIMBERLY-CLARK GLOBAL SALES, INC.
Model
Pad, Tampon
Device description
U BY KOTEX MIXPROD DSP
Published
2021-01-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HEBTampon, menstrual, unscented
HHDPad, menstrual, unscented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEBTampon, Menstrual, UnscentedObstetrics/Gynecology2
HHDPad, Menstrual, UnscentedObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00036000538038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00036000538038000360005380380360005380380036000538038

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual pad, unscentedA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight9Gram
Weight12Gram

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)335-6839xxx@xxx.xxx

Regulatory Flags#

DUNS number
829568273
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00036000586329U by KotexTampon; Pad2026-02-18
00036000596168U by KotexTampon; Pad2026-02-18
00036000597295U by KotexTampon; Pad2026-02-18
10036000563068U By KotexKOTEX TAMPONS2024-09-06
10036000373056U by KotexTampon2016-09-23
10036000426639U by KotexTampon2016-09-23
10036000426660U by KotexTampon2016-09-23
10036000448273U by KotexTampon2016-09-23
10036000472889U by KotexTampon2017-03-27
10036000475392U by KotexTampon2017-10-11
10036000475446U by KotexTampon2017-10-10
10036000477334U by KotexTampon2017-09-21
00036000151657U by KotexTampon2016-09-23
00036000157338U by KotexTampon2016-09-23
00036000159349U by KotexTampon2016-09-23
00036000373059U by KotexTampon2016-09-23
00036000423402U by KotexTampon2016-09-23
00036000426632U by KotexTampon2016-09-23
00036000426663U by KotexTampon2016-09-23
00036000435764U by KotexTampon2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810042480572CoraCoraHHD2026-02-16
10198926000307BIOPURE Quest USA Corp.HEB2025-03-01
10198926000314BIOPURE Quest USA Corp.HEB2025-03-01
10198926000338BIOPURE Quest USA Corp.HEB2025-03-01
10198926000352BIOPURE Quest USA Corp.HEB2025-03-01
09336798002249MoxieThe trustee for Millie & More Unit TrustHEB2025-02-06
09336798002324MoxieThe trustee for Millie & More Unit TrustHHD2025-02-06
09336798002331MoxieThe trustee for Millie & More Unit TrustHHD2025-02-06
09336798002348MoxieThe trustee for Millie & More Unit TrustHHD2025-02-06
20080196313331MEDLINEMEDLINE INDUSTRIES, INC.HHD2024-12-25
20080196781499MEDLINEMEDLINE INDUSTRIES, INC.HHD2024-12-24
00030772162217TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2024-08-07
00032251911798Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911804Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911842Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911859Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911866Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911873Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911880Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911897Family WellnessFamily Dollar StoresHEB2024-07-08
09421904034037OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034044OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034051OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034433OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034440OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034457OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034495OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034501OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034921OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
20080196572875MedlineMEDLINE INDUSTRIES, INC.HHD2023-10-20