FDA.report

U By Kotex

Primary DI
10036000540458
Brand
U By Kotex
Company
KIMBERLY-CLARK GLOBAL SALES, INC.
Model
Pad
Device description
U BY KOTEX SUPRPREM OVRNTE PANTS DREAMWEAR LRG 5
Published
2021-03-19
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
10036000540458PackageGS13In Commercial Distribution
00036000540451PrimaryGS10
00036000536768Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1003600054045810036000540458
00036000540451000360005404510360005404510036000540451
00036000536768000360005367680360005367680036000536768

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
5
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

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