FDA.reportPublic FDA data

MonthlyCup

Primary DI
07350087460338
Brand
MonthlyCup
Company
Monthlycup AB
Model
MonthlyCup Mini Blue Sapphire – box
Device description
MonthlyCup Mini Blue Sapphire – packed in box
Published
2018-04-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
HHECup, Menstrual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHECup, MenstrualObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350087460338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350087460338073500874603387350087460338

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual cup, non-latex, reusableA cup-like receptacle placed by the user into the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. It is a small, soft device made of a biocompatible synthetic material (e.g., silicone elastomer) and is normally available [non-prescription] over-the-counter (OTC). It is typically removed from the vagina by pulling on a protruding stem; depending upon design, it may or may not touch the cervix. The device can function as an alternative to tampons. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height2.17Inch
Width1.46Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
352661030
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350087461021MonthlyCupMonthlyCup Plus Black Pearl - Bag2019-06-17
07350087461038MonthlyCupMonthlyCup Normal Black Pearl – bag2019-06-17
07350087461045MonthlyCupMonthlyCup Mini Black Pearl – bag2019-06-17
07350087460130MonthlyCupMonthlyCup Mini2018-01-24
07350087460147MonthlyCupMonthlyCup Normal2018-01-24
07350087460154MonthlyCupMonthlyCup Plus2018-01-24
07350087460161MonthlyCupMonthlyCup Plus2018-01-24
07350087460208MonthlyCupMonthlyCup Mini2018-01-24
07350087460215MonthlyCupMonthlyCup Normal2018-01-24
07350087460291MonthlyCupMonthlyCup Mini Blue Sapphire – bag2018-04-10
07350087460345MonthlyCupMonthlyCup Normal Blue Sapphire – bag2018-04-10
07350087460390MonthlyCupMonthlyCup Normal Blue Sapphire – box2018-04-10
07350087460413MonthlyCupMonthlyCup Plus Blue Sapphire – bag2018-04-10
07350087460451MonthlyCupMonthlyCup Plus Blue Sapphire – box2018-04-10
07350087460666MonthlyCupMonthlyCup Mini Pink Topaz - Bag2018-11-27
07350087460697MonthlyCupMonthlyCup Mini Pink Topaz – box2018-11-27
07350087460727MonthlyCupMonthlyCup Normal Pink Topaz – bag2018-11-27
07350087460758MonthlyCupMonthlyCup Normal Pink Topaz – box2018-11-27
07350087460789MonthlyCupMonthlyCup Plus Pink Topaz - Bag2018-11-27
07350087460819MonthlyCupMonthlyCup Plus Pink Topaz – box2018-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810050724241Saalt Menstrual DiscSaalt, LLCHHE2026-07-13
00050428087701The DivaCupDiva International IncHHE2026-03-31
00050428088852The DivaCupDiva International IncHHE2026-03-31
00850037498390FlexThe Flex CompanyHHE2025-11-05
00860012792801LunableYayoi FemTech Inc.HHE2025-09-02
00841445001326DivaCup ImpactDiva International IncHHE2025-09-01
00841445001333DivaCup ImpactDiva International IncHHE2025-09-01
00841445001340DivaCup ImpactDiva International IncHHE2025-09-01
00850068130221Pixie CupPixie Cup LLCHHE2025-08-02
00860417001393Pixie CupPixie Cup LLCHHE2025-06-26
00869352000348Pixie CupPixie Cup LLCHHE2025-06-26
00715875074840Pixie CupPixie Cup LLCHHE2025-06-25
00850016867742Pixie CupPixie Cup LLCHHE2025-06-25
00850016867780Pixie CupPixie Cup LLCHHE2025-06-24
00860013832001Selaviera CupCASCO BAY MOLDING LTD.HHE2025-06-18
00860013832018Selaviera CupCASCO BAY MOLDING LTD.HHE2025-06-18
00860013832025Selaviera CupCASCO BAY MOLDING LTD.HHE2025-06-18
00850037498420FlexThe Flex CompanyHHE2025-06-12
10850037498427FlexThe Flex CompanyHHE2025-06-12
09421907199696Hello PeriodTHE HELLO CUP COMPANY LIMITEDHHE2025-06-10
07898976999007Mestrual disc clear SmallINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999014Mestrual disc clear MediumINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999021Mestrual disc clear HighINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999038Mestrual disc Pink Love SmallINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999045Mestrual disc Pink Love MediumINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999052Mestrual disc Pink Love HighINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999069Mestrual disc Unicorn SmallINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999076Mestrual disc Unicorn MediumINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999083Mestrual disc Unicorn HighINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999090Mestrual cup Pink Love SmallINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09