MeLuna

Basic Information

• Brand Name: MeLuna
• Primary DI: B415CPMB100
• Version / Model: Classic Amethyst Ball Medium Shorty
• Catalog Number: C-PMB-10
• Company Name: MeLuna USA
• Labeler DUNS: 026952939
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-17
• Public Version: 4
• Public Version Date: 2020-07-07
• Public Version Status: Update
• Public Device Record Key: f5bf6236-8e41-48bd-b3cb-0bed358c3b4d

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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• 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	B415CPMB100	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K140626	000