FDA.report

U by Kotex

Primary DI
10036000424932
Brand
U by Kotex
Company
KIMBERLY-CLARK GLOBAL SALES, INC.
Model
Pad
Device description
U BY KOTEX SUPER PREMIUM CURVES PANTILINERS 40
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

Related Records

Contact Domains

Product Codes

CodeName
HHDPad, menstrual, unscented

Product Code Classifications

CodeDeviceSpecialtyClass
HHDPad, Menstrual, UnscentedObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10036000424932PackageGS18In Commercial Distribution
00036000424935PrimaryGS10
00036000536744Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1003600042493210036000424932
00036000424935000360004249350360004249350036000424935
00036000536744000360005367440360005367440036000536744

GMDN Terms

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

Contacts

PhoneEmail
+1(800)335-6839xxx@xxx.xxx

Regulatory Flags

DUNS number
829568273
Device count
40
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 DIBrandModelCatalogPublished
00036000586329U by KotexTampon; Pad2026-02-18
00036000596168U by KotexTampon; Pad2026-02-18
00036000597295U by KotexTampon; Pad2026-02-18
00036000465693PoisePessary2016-09-23
00036000470628PoisePessary2017-02-15
00036000475753PoisePessary2017-10-10
00036000491371PoisePessary2018-01-19
10036000465690PoisePessary2016-09-23
10036000470595PoisePessary2017-02-15
10036000470601PoisePessary2017-02-15
10036000470618PoisePessary2017-02-15
10036000470625PoisePessary2017-02-15
10036000491378PoisePessary2018-01-19
00036000565430U By KotexTampon2024-10-31
00036000565447U By KotexTampon2024-10-31
00036000565454U By KotexTampon2024-10-31
10036000563068U By KotexKOTEX TAMPONS2024-09-06
00036000373042U by KotexPad2018-01-03
00036000424911U by KotexPad2018-01-03
00036000448269U by KotexPad2018-01-03

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00036000586329U by KotexKIMBERLY-CLARK GLOBAL SALES, INC.HHD2026-02-18
00036000596168U by KotexKIMBERLY-CLARK GLOBAL SALES, INC.HHD2026-02-18
20810042482351CoraCoraHHD2026-02-16
20810042482368CoraCoraHHD2026-02-16
00050428057186CVSHealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDHHD2026-02-04
00050428073421CVSHealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDHHD2026-02-04
00050428080863CVSHealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDHHD2026-02-04
00628719704004Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628719704011Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628719704035Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628719704042Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628719704059Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628719704554Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628719704561Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628719704578Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628719704592Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628719704608Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628719704615Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628719704646Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628719704660Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628719704677Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628719704684Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628942539312Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628942539343Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628942539350Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628942539367Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628942539374Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628942539381Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628942539398Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628942539473Iris + ArloIris + Arlo Inc.HHD2026-01-06