Diva

Basic Information

• Brand Name: Diva
• Primary DI: 00841445001678
• Version / Model: 1
• Company Name: Diva International Inc
• Labeler DUNS: 207651758
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-27
• Public Version: 1
• Public Version Date: 2023-05-05
• Public Version Status: New
• Public Device Record Key: 2b1315d9-3d30-4363-ac71-b0ce56403740

Device Description

Menstrual Disc, medical grade silicone non-latex, soft reusable disc placed by the user into the vagina, help in place by the pelvic muscles, and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons. It is available OTC (Over the Counter). It is removed from the vagina by pulling on the pull tab. This is a reusable device for a single user.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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	00841445001678	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]