FDA.reportPublic FDA data

Besmed Menstrual Cup

Primary DI
04716770341460
Brand
Besmed Menstrual Cup
Company
BESMED HEALTH BUSINESS CORP.
Model
PE-34146
Device description
Small White Menstrual Cup
Published
2022-12-08
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
04716770341460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04716770341460047167703414604716770341460

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual cup/disc, non-latex, reusableA cup-like or disc-shaped 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 typically removed from the vagina by pulling on a protruding stem/ring or by insertion of a finger to catch its rim. The device can function as an alternative to tampons and may remain in situ during sexual intercourse. This is a reusable device.

Sterilization Methods#

Method table
Method
Microwave Radiation

Regulatory Flags#

DUNS number
658023775
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04716770703022HMEF W/Luer lock port (Dead space 45ml)FL-703022026-02-11
04716770703039HMEF W/Luer lock port (Dead space 60ml)FL-703032026-02-11
04716770703060HMEF (Dead space 60ml)FL-703062026-02-11
04716770701127HME W/Luer lock port (Dead space 45ml)FL-701122026-02-11
04716770701158Angled HME with luer lock portFL-701152026-02-11
04716770702230Bacterial Filter (Dead space 32ml)FL-702232026-02-11
14716770703029HMEF W/Luer lock port (Dead space 45ml)FL-703022026-02-11
14716770703036HMEF W/Luer lock port (Dead space 60ml)FL-703032026-02-11
14716770703067HMEF (Dead space 60ml)FL-703062026-02-11
04716770341477Besmed Menstrual CupPE-341472022-12-08
04716770341484Besmed Menstrual CupPE-341482022-12-09
04716770341491Besmed Menstrual CupPE-341492022-12-09
04716770931005INCENTIVE SPIROMETER,600/900/1200MLTB-931002016-09-06
04716770932507INCENTIVE SPIROMETER,2500MLTB-932502016-09-06
04716770932514 INCENTIVE SPIROMETERTB-932512017-12-15
04716770935003 INCENTIVE SPIROMETER,5000MLTB-935002016-09-06
04716770935010 INCENTIVE SPIROMETERTB-935012017-12-15
04716770790015Elbow connetor 18MM ID for nebulizerMP-790012017-12-13
04716770791043MOUTH PIECE (OD:18mm,22mm)MP-791042017-12-13
04716770791081MOUTH PIECE(OD:22mm)MP-791082017-12-13

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