Medegen Medical Products, LLC

Basic Information

• Brand Name: Medegen Medical Products, LLC
• Primary DI: 00700812003892
• Version / Model: 2565
• Company Name: MEDEGEN MEDICAL PRODUCTS, LLC
• Labeler DUNS: 055527753
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2020-12-20
• Public Version: 2
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 4ada0921-e22f-410b-9ba9-97e9d23fab08

Device Description

Set Vaginal Irrigation 50/c3s 60/plt

Device Characteristics

• Single Use: Yes
• 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: 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
60356	Colonic lavage nozzle, reusable	A hollow device intended to be inserted into the rectum and/or colostomy for the administration of irrigation fluid from a connected colonic lavage system or an enema kit. It is typically consists of a one-piece, hollow moulded shape designed to be connected to the enema/lavage system tubing at its proximal end, and be inserted into the rectum or attach to a colostomy at its distal end. It may be designed for open (entry of fluid only) or closed (entry of fluid and evacuation of waste), and clinical or home-use, colonic lavage. This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00700812003892	GS1
Unit of Use	10700812003899	GS1