Home GUDID 00700812003892 Medegen Medical Products, LLC
Primary DI 00700812003892
Brand Medegen Medical Products, LLC
Company MEDEGEN MEDICAL PRODUCTS, LLC
Model 2565
Device description Set Vaginal Irrigation 50/c3s 60/plt
Published 2020-12-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name HED DOUCHE APPARATUS, VAGINAL, THERAPEUTIC
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HED Douche Apparatus, Vaginal, Therapeutic Obstetrics/Gynecology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00700812003892 Primary GS1 0 10700812003899 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00700812003892 00700812003892 700812003892 0700812003892 10700812003899 10700812003899
GMDN Terms# Term, Definition table Term Definition Colonic lavage nozzle, non-sterile, reusable A non-sterile, 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.
Regulatory Flags# DUNS number 055527753 Device count 50 Premarket exempt true Lot or batch true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published H3621580 Medegen Medical products 158 158 2016-09-23 H362158TY0 Medegen Medical products 158TY 158TY 2016-09-23 H362158V0 Medegen Medical products 158V 158V 2016-09-23 H3621780 Medegen Medical products 178 178 2016-09-23 H362178TY0 Medegen Medical products 178TY 178TY 2016-09-23 H362178V0 Medegen Medical products 178V 178V 2016-09-23 H3621800 Medegen Medical products 180 180 2016-09-23 H362180S0 Medegen Medical products 180S 180S 2016-09-23 H362180TY0 Medegen Medical products 180TY 180TY 2016-09-23 H362180V0 Medegen Medical products 180V 180V 2016-09-23 H3621820 Medegen Medical products 182 182 2016-09-23 H362182S0 Medegen Medical products 182S 182S 2016-09-23 H362182TY0 Medegen Medical products 182TY 182TY 2016-09-23 H362182V0 Medegen Medical products 182V 182V 2016-09-23 H3621840 Medegen Medical products 184 184 2016-09-23 H362184CN0 Medegen Medical products CN184 CN184 2016-09-23 H362184R0 Medegen Medical products 184R 184R 2016-09-23 H362184S0 Medegen Medical products 184S 184S 2016-09-23 H362184TY0 Medegen Medical products 184TY 184TY 2016-09-23 H3621850 Medegen Medical products 185 185 2016-09-23
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