FDA.reportPublic FDA data

FEMTEX

Primary DI
00748364101758
Brand
FEMTEX
Company
FIRST QUALITY HYGIENIC, INC.
Model
FT21804SA
Device description
SUPER 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
00748364101758PrimaryGS10
00074836410173Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00748364101758007483641017587483641017580748364101758
00074836410173000748364101730748364101730074836410173

Sterilization Methods#

Method table
Method

Regulatory Flags#

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