FDA.reportPublic FDA data

Core Values Tampons

Primary DI
10834533000971
Brand
Core Values Tampons
Company
HARMON STORES, INC.
Model
BHAXS18
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
10834533000971PackageGS112In Commercial Distribution
00834533000974PrimaryGS10
07290016625288Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1083453300097110834533000971
00834533000974008345330009748345330009740834533000974
07290016625288072900166252887290016625288

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
06972465050002Borage MedicalSuzhou Borage Medical Technology Co.,Ltd.HEB2026-10-10
06972465050309Borage MedicalSuzhou Borage Medical Technology Co.,Ltd.HEB2026-10-10
06972465050323Borage MedicalSuzhou Borage Medical Technology Co.,Ltd.HEB2026-10-09
06972465050361Borage MedicalSuzhou Borage Medical Technology Co.,Ltd.HEB2026-10-09
05060994741759DayeTAMPON INNOVATIONS LTD OODHEB2026-10-07
05060994741766DayeTAMPON INNOVATIONS LTD OODHEB2026-10-07
05060994741773DayeTAMPON INNOVATIONS LTD OODHEB2026-10-07
05060994741780DayeTAMPON INNOVATIONS LTD OODHEB2026-10-07
08806011638117Dong-A Pharmaceutical Co., Ltd.Dong-A Pharmaceutical Co., Ltd.HEB2026-09-29
05060994740752DayeTAMPON INNOVATIONS LTD OODHEB2026-09-25
05060994740769DayeTAMPON INNOVATIONS LTD OODHEB2026-09-25
00036000602579KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602586KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602593KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602609KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602616KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602647KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602654KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602661KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000606126KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00073010720091TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010720831TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721173TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721210This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721227TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721272TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721333This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721340TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721517This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721524This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25