FDA.reportPublic FDA data

Core Values Tampons

Primary DI
10834533000964
Brand
Core Values Tampons
Company
HARMON STORES, INC.
Model
BHAXR18
Published
2017-07-31
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
K140077000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140077000ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTEDAlbaad , Ltd.2014-09-22HEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10834533000964PackageGS112In Commercial Distribution
00834533000967PrimaryGS10
07290016625271Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1083453300096410834533000964
00834533000967008345330009678345330009670834533000967
07290016625271072900166252717290016625271

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
804085293
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
00017276223798Core Values0172762237982020-08-10
00017276223828Core Values0172762238282020-08-10
00017276224702Core Values0172762247022020-08-10
00017276224719Core Values0172762247192020-08-10
00017276224900Core Values0172762249002020-08-10
00017276225402Core Values0172762254022020-08-10
00017276225747Core Values0172762257472020-08-10
00017276226485Core Values0172762264852020-08-10
00017276226492Core Values0172762264922020-08-10
00017276226515Core Values0172762265152020-08-10
00017276226522Core Values0172762265222020-08-10
00017276226546Core Values0172762265462020-08-10
00017276226553Core Values0172762265532020-08-10
00017276226591Core Values0172762265912020-08-10
00017276226607Core Values0172762266072020-08-10
00017276227963Core Values0172762279632020-08-10
00017276227970Core Values0172762279702020-08-10
00017276227987Core Values0172762279872020-08-10
00017276228595Core Values0172762285952020-08-10
00017276229745Core Values0172762297452020-08-10

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