Flex Cup

Basic Information

• Brand Name: Flex Cup
• Primary DI: 00851906007200
• Version / Model: Single Flex Cup Full Fit (Size 2) box
• Company Name: The Flex Company
• Labeler DUNS: 080314616
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-15
• Public Version: 3
• Public Version Date: 2022-01-26
• Public Version Status: Update
• Public Device Record Key: 8fdc0717-9001-44f7-9b43-2f640d8a252f

Device Description

Single Flex Cup Full Fit (Size 2), English only

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
47723	Menstrual cup, non-latex, single-use	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 typically made of a biocompatible synthetic materials (e.g., low density polyethylene) and is typically removed from the vagina by pulling on a protruding stem or by insertion of a finger to catch its rim; depending upon design, it may or may not touch the cervix. The device can function as an alternative to tampons and may remain in situ during sexual intercourse. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20851906007198	GS1	Case	6	In Commercial Distribution
Package	10851906007191	GS1	Inner Pack	3	In Commercial Distribution
Primary	00851906007200	GS1

Customer Contacts

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