FDA.reportPublic FDA data

U by Kotex

Primary DI
10036000449966
Brand
U by Kotex
Company
KIMBERLY-CLARK GLOBAL SALES, INC.
Model
Tampon
Device description
U BY KOTEX PREMIUM SECURITY SUPER PLUS TAMPONS
Published
2019-04-02
Public version status
New
Distribution status
Not 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
HEBTAMPON, MENSTRUAL, UNSCENTED

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141294000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141294000U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONSKimberly-Clark Corp.2014-08-25HEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10036000449966PackageGS16Not in Commercial Distribution
00036000449969PrimaryGS10
00036000998443Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003600044996610036000449966
00036000449969000360004499690360004499690036000449969
00036000998443000360009984430360009984430036000998443

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
Weight15Gram

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
829568273
Device count
21
DM exempt
false
Premarket exempt
false
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
00036000602579KotexTampon2026-09-20
00036000602586KotexTampon2026-09-20
00036000602593KotexTampon2026-09-20
00036000602609KotexTampon2026-09-20
00036000602616KotexTampon2026-09-20
00036000602647KotexTampon2026-09-20
00036000602654KotexTampon2026-09-20
00036000602661KotexTampon2026-09-20
00036000606126KotexTampon2026-09-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060994740752DayeTAMPON INNOVATIONS LTD OODHEB2026-09-25
05060994740769DayeTAMPON INNOVATIONS LTD OODHEB2026-09-25
00036000602579KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602586KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602593KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602609KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602616KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602647KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602654KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602661KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000606126KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
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