FDA.reportPublic FDA data

Smart Sense Tampons

Primary DI
10883967382269
Brand
Smart Sense Tampons
Company
KMART HOLDING CORPORATION
Model
BKMGS18
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
HEBTampon, Menstrual, Unscented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEBTampon, Menstrual, UnscentedObstetrics/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
10883967382269PackageGS112In Commercial Distribution
00883967382262PrimaryGS10
07290016625127Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088396738226910883967382269
00883967382262008839673822628839673822620883967382262
07290016625127072900166251277290016625127

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual tampon, unscentedA non-sterile, non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual or other vaginal 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
10883967382245Smart Sense TamponsBKMSGR182016-09-20
10883967382252Smart Sense TamponsBKMSGS182016-09-20
10883967418340SMART SENSE TamponsBKMGR362017-05-02
10883967418364SMART SENSE TamponsBKMSGP362017-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195893628032Organic Light Tampons-8ctTPC Inc.HEB2026-05-28
00195893724130Organic Super Tampons-8ctTPC Inc.HEB2026-05-28
00195893932832Organic Regular Tampons-8ctTPC Inc.HEB2026-05-28
00196852297061Organic Light Tampons-16ct Original PackagingTPC Inc.HEB2026-05-28
00196852637379Organic Super Tampons-16ct Original PackagingTPC Inc.HEB2026-05-28
00196852929245Organic Regular Tampons-16ct Original PackagingTPC Inc.HEB2026-05-28
00860010723173Organic Regular Tampons-550ctTPC Inc.HEB2026-05-28
00860012610303Organic Regular and Super Tampons-16ctTPC Inc.HEB2026-05-28
00860012610310Organic Regular Tampons-16ctTPC Inc.HEB2026-05-28
00860013110925Organic Super Tampons-16ctTPC Inc.HEB2026-05-28
00860013110932Organic Light Tampons-16ctTPC Inc.HEB2026-05-28
00860013110956Organic Light Tampons-24ctTPC Inc.HEB2026-05-28
00860013110963Organic Super Tampons-24ctTPC Inc.HEB2026-05-28
00860014539909Organic Multi Super and Super Plus Tampons-16ctTPC Inc.HEB2026-05-28
00860014539916Organic Multi Light Regular and Super Tampons-16ctTPC Inc.HEB2026-05-28
00860014539961Organic Light Tampons-36ctTPC Inc.HEB2026-05-28
00860014539978Organic Regular Tampons-36ctTPC Inc.HEB2026-05-28
00860014539985Organic Super Tampons-36ctTPC Inc.HEB2026-05-28
00860014539992Organic Multi Regular and Super Tampons-36ctTPC Inc.HEB2026-05-28
00860015263407Organic Multi Super and Super Plus Tampons-36ctTPC Inc.HEB2026-05-28
00860015263414Organic Multi Light Regular and Super Tampons-36ctTPC Inc.HEB2026-05-28
00860015263445Organic Super Plus Tampons-36ctTPC Inc.HEB2026-05-28
00860012610389Organic Regular Tampons-24ctTPC Inc.HEB2026-05-14
00860012610372Organic Multi Regular and Super Tampons-24ctTPC Inc.HEB2026-05-13
00036000586329U by KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-02-18
00036000596168U by KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-02-18
10198926000307BIOPURE Quest USA Corp.HEB2025-03-01
10198926000314BIOPURE Quest USA Corp.HEB2025-03-01
10198926000338BIOPURE Quest USA Corp.HEB2025-03-01
10198926000352BIOPURE Quest USA Corp.HEB2025-03-01