FEMTEX

Primary DI
00748364102007
Brand
FEMTEX
Company
FIRST QUALITY HYGIENIC, INC.
Model
FT11812SO
Device description
regular scented plastic applicator tampons
Published
2016-08-19
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
00748364102007PrimaryGS10
00074836410203Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00748364102007007483641020077483641020070748364102007
00074836410203000748364102030748364102030074836410203

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual tampon, scentedA non-sterile plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual or other vaginal discharge. It is scented for aesthetic and deodorizing purposes to counter odorous smells resulting from the discharge. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806731840
Device count
18
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00032251152023Family Wellness Tampons 1000025102018-06-22
00032251186615Family Wellness Tampons 100012032018-06-22
00032251186622Family Wellness Tampons100012012018-06-22
00032251186639Family Wellness Tampons 100012022018-06-22
00032251333989Family Wellness Tampons 100016882018-06-22
00032251432767Family Wellness Tampons 1000028442018-06-22
00032251432774Family Wellness Tampons 1000028432018-06-22
00032251435157Family Wellness Tampons 1000030752018-06-22
10032251152020Family Wellness Tampons 1000025102018-06-22
10032251186612Family Wellness Tampons 100012032018-06-22
10032251186629Family Wellness Tampons100012012018-06-22
10032251186636Family Wellness Tampons 100012022018-06-22
10032251333986Family Wellness Tampons 100016882018-06-22
10032251432764Family Wellness Tampons 1000028442018-06-22
10032251432771Family Wellness Tampons 1000028432018-06-22
10032251435154Family Wellness Tampons 1000030752018-06-22
00748364100089FEMTEXFT10824F/12016-08-15
00748364100096FEMTEXFT20824F/12016-08-16
00748364100102FEMTEXFT30824F/12016-08-16
00748364100225FEMTEXFT12004F2016-08-16

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
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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