FDA.reportPublic FDA data

FRED'S TAMPONS

Primary DI
00084579122479
Brand
FRED'S TAMPONS
Company
FRED'S, INC.
Model
FR11806SO
Device description
REGULAR SCENTED PLASTIC APPLICATOR TAMPONS
Published
2016-09-13
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
10084579122476PackageGS16In Commercial Distribution
00084579122479PrimaryGS10
00008457912242Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1008457912247610084579122476
00084579122479000845791224790845791224790084579122479
00008457912242000084579122420084579122420008457912242

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
005866116
Device count
18
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00084579122424FRED'S TAMPONS FR12006F/22016-09-13
00084579122431FRED'S TAMPONS FR22006F/22016-09-13
00084579122455FRED'S TAMPONS FR11806UO2016-09-13
00084579122462FRED'S TAMPONS FR21806UO/22016-09-13
00084579122486FRED'S TAMPONS FR21806S0/22016-09-13
00084579123032FRED'S TAMPONS FR32006F/22016-09-13
10084579122421FRED'S TAMPONS FR12006F/22016-09-13
10084579122438FRED'S TAMPONS FR22006F/22016-09-13
10084579122452FRED'S TAMPONS FR11806UO2016-09-13
10084579122469FRED'S TAMPONS FR21806UO/22016-09-13
10084579122476FRED'S TAMPONS FR11806SO2016-09-13
10084579122483FRED'S TAMPONS FR21806S0/22016-09-13
10084579123039FRED'S TAMPONS FR32006F/22016-09-13
00761059407577Fred's Unifine Pentips Plus - Micro 4mmx32GAN 3840FRDAN 3840FRD2016-09-19
00084579128570FRED'S SUPER DOLLAR2684962016-09-30
00084579128587FRED'S SUPER DOLLAR6371492016-09-30
00761059307570Fred's Unifine Pentips Plus - Short 8mmx31GAN 3830FRDAN 3830FRD2016-09-19
00761059842576Fred's Unifine Pentips Plus - Micro 4mmx32GAN 3840FRDAN 3840FRD2016-09-19
00761059507574Fred's Unifine Pentips Plus - Mini 5mmx31GAN 3850FRDAN 3850FRD2016-09-19
00084579118625Fred's Pharmacy118622016-09-16

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