FDA.reportPublic FDA data

Amazon Basics

Primary DI
10195515017944
Brand
Amazon Basics
Company
AMAZON.COM SERVICES LLC
Model
B098VHYX2M
Catalog number
B098VHYX2M
Device description
Amazon Basics Menstrual Cup
Published
2021-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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
10195515017944PackageGS1100In Commercial Distribution
00195515017947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019551501794410195515017944
00195515017947001955150179471955150179470195515017947

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 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

Contacts#

Phone, Email table
PhoneEmail
+1(877)485-0385xxx@xxx.xxx

Regulatory Flags#

DUNS number
128990418
Device count
1
DM exempt
true
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195515153287Amazon Basics6304336304332026-08-07
00195515153294Amazon Basics6304336304332026-08-07
00195515147552Amazon20002241N/A2026-02-20
00195515147545Amazon20002240N/A2026-02-20
00195515050098AmazonDigital Pregnancy TestN/A2025-05-20
00195515045902AmazonEarly Result Pregnancy Test2025-05-20
00195515017947Amazon BasicsB098VHYX2MB098VHYX2M2021-10-27
10195515045909AmazonEarly Result Pregnancy Test2025-05-20
10195515050095AmazonDigital Pregnancy TestN/A2025-05-20
00195515045247Amazon BasicsSQN542025-01-25
10195515045244Amazon BasicsSQN542025-01-25
00195515047944Amazon Basic Care B09S3W7SW72023-12-21
00195515047098ABC1955150470982024-06-25
00195515047104ABC1955150471042024-06-25
10195515047095ABC1955150470982024-06-25
10195515047101ABC1955150471042024-06-25
00195515047951Amazon Basic Care B09S3VLQLL2023-12-21
00195515047968Amazon Basic CareB095S3WFGQB2023-12-21
10195515047958Amazon Basic Care B09S3VLQLL2023-12-21
10195515047965Amazon Basic CareB095S3WFGQB2023-12-21

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