Flents

Basic Information

• Brand Name: Flents
• Primary DI: 00025715652009
• Version / Model: 65200
• Company Name: APOTHECARY PRODUCTS, LLC
• Labeler DUNS: 092312735
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-16
• Public Version: 1
• Public Version Date: 2020-11-24
• Public Version Status: New
• Public Device Record Key: b0e2f920-047a-45de-9747-6a0f246a47cb

Device Description

FLENTS DOUCHE KIT

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HED	Douche Apparatus, Vaginal, Therapeutic	Obstetrics/Gynecology	884.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32616	Vaginal douche, reusable	A manual device designed to produce and direct a stream of fluid (typically water, water/vinegar solution, or antiseptic chemicals) into the vaginal cavity typically for hygienic purposes, including the removal of vaginal discharge, medicinal deposits, and anticonceptual products from the vagina. It usually consists of a bag, bottle, or bulb to contain the fluid, and tubing often with a nozzle for vaginal insertion; the fluid is ejected upon hand compression by the user. The device is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10025715040742	GS1	case	12	In Commercial Distribution
Primary	00025715652009	GS1

Customer Contacts

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