FDA.reportPublic FDA data

CareOne Tampons

Primary DI
10041520039917
Brand
CareOne Tampons
Company
Ahold U.S.A., Inc.
Model
CA21812UO/1
Device description
SUPER UNSCENTED PLASTIC APPLICATOR TAMPONS
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HEBTampon, Menstrual, Unscented

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10041520039917PackageGS112In Commercial Distribution
00041520039910PrimaryGS10
00004152003995Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004152003991710041520039917
00041520039910000415200399100415200399100041520039910
00004152003995000041520039950041520039950004152003995

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
170199058
Device count
18
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
00041520078438CareOne0415200784382019-08-30
00041520010704CareOne0415200107042019-06-28
00041520013965CareOne0415200139652020-09-27
00041520014009CareOne0415200140092019-06-28
00041520019714CareOne0415200197142019-06-28
00041520089298CareOne0415200892982019-07-31
00041520089304CareOne0415200893042019-06-28
00041520096777CareOne0415200967772019-07-31
00041520096784CareOne0415200967842019-07-31
00041520096791CareOne0415200967912019-06-28
00041520096821CareOne0415200968212019-06-28
00041520125033CareOne0415201250332019-07-31
00041520875754CareOne0415208757542019-06-28
00041520877710CareOne0415208777102019-06-28
00041520877727CareOne0415208777272019-06-28
00041520880963CareOne0415208809632019-06-28
00341520317170CareOne3415203171702020-09-27
00341520877889CareOne3415208778892019-07-31
00041520171283Care OneDigital Pregnancy Test2021-04-22
00041520171269Care OneOne Step Pregnancy Test2021-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00036000586329U by KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-02-18
00036000596168U by KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-02-18
10198926000307BIOPURE Quest USA Corp.HEB2025-03-01
10198926000314BIOPURE Quest USA Corp.HEB2025-03-01
10198926000338BIOPURE Quest USA Corp.HEB2025-03-01
10198926000352BIOPURE Quest USA Corp.HEB2025-03-01
09336798002249MoxieThe trustee for Millie & More Unit TrustHEB2025-02-06
00030772162217TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2024-08-07
00032251911798Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911804Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911842Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911859Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911866Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911873Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911880Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911897Family WellnessFamily Dollar StoresHEB2024-07-08
09421904034037OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034044OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034051OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034433OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034440OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034457OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034495OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034501OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034921OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
10075289065009Comfort PlusTRANZONIC COMPANIES, THEHEB2023-06-12
10075289064965Comfort PlusTRANZONIC COMPANIES, THEHEB2022-12-30
10075289064941Comfort PlusTRANZONIC COMPANIES, THEHEB2022-11-14
10075289064958Comfort PlusTRANZONIC COMPANIES, THEHEB2022-11-14
10075289064972Comfort PlusTRANZONIC COMPANIES, THEHEB2022-11-14