FDA.reportPublic FDA data

Smart Sense Tampons

Primary DI
10883967382245
Brand
Smart Sense Tampons
Company
KMART HOLDING CORPORATION
Model
BKMSGR18
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
K042773000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042773000ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONSRostam , Ltd.2004-11-23HIL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10883967382245PackageGS112In Commercial Distribution
00883967382248PrimaryGS10
07290016625158Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088396738224510883967382245
00883967382248008839673822488839673822480883967382248
07290016625158072900166251587290016625158

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
131978533
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
false
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
00072000758359Guaranteed Quality ProductsKD-1202016-09-20
00072000783894Guaranteed Quality ProductsKD-1812016-09-20
00072000764978Guaranteed Quality ProductsKD-16312016-09-20
00883967296910Image Essentials One Step Pregnancy TestFPPL2016-07-04
00883967296927Image Essentials One Step Pregnancy TestFPPL2016-07-04
00072000793138Smart Sense Early Result Pregnancy TestPLPL2016-07-04
00883967382231Smart Sense TamponsBKMGR182016-09-20
00883967382248Smart Sense TamponsBKMSGR182016-09-20
00883967382255Smart Sense TamponsBKMSGS182016-09-20
00883967382262Smart Sense TamponsBKMGS182016-09-20
00883967418343SMART SENSE TamponsBKMGR362017-05-02
00883967418350SMART SENSE TamponsBKMUR182017-05-02
00883967418367SMART SENSE TamponsBKMSGP362017-05-02
00883967418374SMART SENSE TamponBKMPS502017-05-02
00883967418381SMART SENSE TamponsBKMXC362017-05-02
10883967382238Smart Sense TamponsBKMGR182016-09-20
10883967382252Smart Sense TamponsBKMSGS182016-09-20
10883967382269Smart Sense TamponsBKMGS182016-09-20
10883967418340SMART SENSE TamponsBKMGR362017-05-02
10883967418364SMART SENSE TamponsBKMSGP362017-05-02

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