FDA.reportPublic FDA data

MeLuna

Primary DI
B415CSMB000
Brand
MeLuna
Company
MeLuna USA
Model
Classic Clear Ball Medium Standard
Catalog number
C-SMB-00
Published
2016-11-17
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140626000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140626000MELUNA CLASSIC/SPORT MENSTRUAL CUPMeluna2014-07-10HHE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B415CSMB000PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
026952939
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B415CPLB000MeLunaClassic Clear Ball Large ShortyC-PLB-002016-11-17
B415CPLB100MeLunaClassic Amethyst Ball Large ShortyC-PLB-102016-11-15
B415CPLB200MeLunaClassic Sapphire Ball Large ShortyC-PLB-202016-11-17
B415CPLR000MeLunaClassic Clear Ring Large ShortyC-PLR-002016-11-17
B415CPLR100MeLunaClassic Amethyst Ring Large ShortyC-PLR-102016-11-15
B415CPLR200MeLunaClassic Sapphire Ring Large ShortyC-PLR-202016-11-17
B415CPLS000MeLunaClassic Clear Stem Large ShortyC-PLS-002016-11-17
B415CPLS100MeLunaClassic Amethyst Stem Large ShortyC-PLS-102016-11-17
B415CPLS200MeLunaClassic Sapphire Stem Large ShortyC-PLS-202016-11-17
B415CPMB000MeLunaClassic Clear Ball Medium ShortyC-PMB-002016-11-17
B415CPMB100MeLunaClassic Amethyst Ball Medium ShortyC-PMB-102016-11-17
B415CPMB200MeLunaClassic Sapphire Ball Medium ShortyC-PMB-202016-11-17
B415CPMR000MeLunaClassic Clear Ring Medium ShortyC-PMR-002016-11-17
B415CPMR100MeLunaClassic Amethyst Ring Medium ShortyC-PMR-102016-11-17
B415CPMR200MeLunaClassic Sapphire Ring Medium ShortyC-PMR-202016-11-17
B415CPMS000MeLunaClassic Clear Stem Medium ShortyC-PMS-002016-11-17
B415CPMS100MeLunaClassic Amethyst Stem Medium ShortyC-PMS-102016-11-17
B415CPMS200MeLunaClassic Sapphire Stem Medium ShortyC-PMS-202016-11-17
B415CPSB000MeLunaClassic Clear Ball Small ShortyC-PSB-002016-11-17
B415CPSB100MeLunaClassic Amethyst Ball Small ShortyC-PSB-102016-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07898976999106Mestrual cup Pink Love MediumINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09