FDA.reportPublic FDA data

U by Kotex

Primary DI
00036000506907
Brand
U by Kotex
Company
KIMBERLY-CLARK GLOBAL SALES, INC.
Model
Pad
Device description
U BY KOTEX SUPER PREMIUM BARELY THERE PANTILINERS 150
Published
2020-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHDPad, menstrual, unscented

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00036000506907PackageGS14In Commercial Distribution
00036000476361PrimaryGS10
00036000536744Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00036000506907000360005069070360005069070036000506907
00036000476361000360004763610360004763610036000476361
00036000536744000360005367440360005367440036000536744

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
829568273
Device count
150
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00036000597295U by KotexKIMBERLY-CLARK GLOBAL SALES, INC.HHD2026-02-18
10810042480572CoraCoraHHD2026-02-16
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
20080196572875MedlineMEDLINE INDUSTRIES, INC.HHD2023-10-20
20885380169363CurityCardinal Health 200, LLCHHD2023-08-01
20885380169370CurityCardinal Health 200, LLCHHD2023-08-01
20885380169387CurityCardinal Health 200, LLCHHD2023-08-01
00032251914690Family WellnessFamily Dollar StoresHHD2023-05-24
00032251914720Family WellnessFamily Dollar StoresHHD2023-05-24
08809372293650Lefresh long panty LinersHeritage Ventures Co.,Ltd.HHD2023-02-13
08809372293872Lefresh regular size with wingsHeritage Ventures Co.,Ltd.HHD2023-02-13
08809372293896Lefresh large size with wingsHeritage Ventures Co.,Ltd.HHD2023-02-13
08809372293919Lefresh super long overnight size with wingsHeritage Ventures Co.,Ltd.HHD2023-02-13
08809372293964Lefresh overnight size with wingsHeritage Ventures Co.,Ltd.HHD2023-02-13
00036000549355U By KotexKIMBERLY-CLARK GLOBAL SALES, INC.HHD2022-09-14
00036000100358U By KotexKIMBERLY-CLARK GLOBAL SALES, INC.HHD2022-08-25
00036000100778U By KotexKIMBERLY-CLARK GLOBAL SALES, INC.HHD2022-08-25
00036000548983U By KotexKIMBERLY-CLARK GLOBAL SALES, INC.HHD2022-08-25
00036000548990U By KotexKIMBERLY-CLARK GLOBAL SALES, INC.HHD2022-08-25
00036000549010U By KotexKIMBERLY-CLARK GLOBAL SALES, INC.HHD2022-08-25
00036000549072U By KotexKIMBERLY-CLARK GLOBAL SALES, INC.HHD2022-08-25
00036000549089U By KotexKIMBERLY-CLARK GLOBAL SALES, INC.HHD2022-08-25
00036000549096U By KotexKIMBERLY-CLARK GLOBAL SALES, INC.HHD2022-08-25
00036000549102U By KotexKIMBERLY-CLARK GLOBAL SALES, INC.HHD2022-08-25
00036000549119U By KotexKIMBERLY-CLARK GLOBAL SALES, INC.HHD2022-08-25
00036000549126U By KotexKIMBERLY-CLARK GLOBAL SALES, INC.HHD2022-08-25