FDA.reportPublic FDA data

U by Kotex

Primary DI
00036000538014
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
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
00036000538014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00036000538014000360005380140360005380140036000538014

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual tampon, unscentedA non-sterile, non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00050428044940CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDHHD2026-05-26
00050428045770CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDHHD2026-05-26
00050428046715CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDHHD2026-05-26
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
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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
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00628942539350Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628942539367Iris + ArloIris + Arlo Inc.HHD2026-01-06
00628942539374Iris + ArloIris + Arlo Inc.HHD2026-01-06