MonthlyCup

Basic Information

• Brand Name: MonthlyCup
• Primary DI: 07350087461045
• Version / Model: MonthlyCup Mini Black Pearl – bag
• Company Name: Monthlycup AB
• Labeler DUNS: 352661030
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-17
• Public Version: 2
• Public Version Date: 2020-07-07
• Public Version Status: Update
• Public Device Record Key: 4f48b5b9-8717-4e2d-94b5-492b58fdc9bf

Device Description

MonthlyCup Mini Black Pearl – packed in bag

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HHE	Cup, Menstrual	Obstetrics/Gynecology	884.5400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47728	Menstrual cup, non-latex, reusable	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350087461045	GS1

Device Sizes

Type	Value	Unit	Text
Width	1.46	Inch
Height	2.17	Inch