FDA.reportPublic FDA data

CareOne Tampons

Primary DI
00041520039934
Brand
CareOne Tampons
Company
Ahold U.S.A., Inc.
Model
CA11812SO/1
Device description
SCENTED REGULAR 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
Single use
true

Product Codes#

Code, Name table
CodeName
HILTampon, Menstrual, Scented, Deodorized

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIL Tampon, Menstrual, Scented, Scented-DeodorizedObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050067000FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONSFirst Quality Hygienic, Inc.2005-02-01HIL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10041520039931PackageGS112In Commercial Distribution
00041520039934PrimaryGS10
00004152003995Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004152003993110041520039931
00041520039934000415200399340415200399340041520039934
00004152003995000041520039950041520039950004152003995

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual tampon, scentedA deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual blood or other vaginal discharge. This is a single-use device.

Regulatory Flags#

DUNS number
170199058
Device count
18
Lot or batch
true
Manufacturing date on label
true

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
00860007113727Every CycleCycle LLCHIL2022-03-10
10834533001428DG HealthDOLGENCORP, LLCHIL2021-09-18
00834533001421DG HealthDOLGENCORP, LLCHIL2021-09-18
00073010631601TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHIL2021-01-22
00073010631632TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHIL2021-01-22
00073010632042TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHIL2021-01-22
00073010632059TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHIL2021-01-22
00073010632127TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHIL2021-01-22
40073010631630TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHIL2021-01-22
40073010632125TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHIL2021-01-22
00078300071129PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2020-04-01
00078300071136PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2020-04-01
00078300071143PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2020-04-01
00078300084808PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2020-04-01
10078300071126PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2020-04-01
10078300071133PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2020-04-01
10078300071140PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2020-04-01
10078300084805PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2020-04-01
00078300098393PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2020-03-03
10078300098390PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2020-03-03
00037000118916TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHIL2019-12-13
00073010024403TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHIL2019-12-13
00078300002178PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2019-04-01
00078300002185PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2019-04-01
00078300002192PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2019-04-01
00078300002208PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2019-04-01
00078300084792PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2019-04-01
00078300089964PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2019-04-01
00078300098331PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2019-04-01
00078300098362PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2019-04-01