Home GUDID 00848657013307 AED
Primary DI 00848657013307
Brand AED
Company NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model 32-4085-TE
Device description ELLIK ADAPTER
Published 2017-11-28
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name KQT EVACUATOR, GASTRO-UROLOGY
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KQT Evacuator, Gastro-Urology Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00848657013307 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00848657013307 00848657013307 848657013307 0848657013307
GMDN Terms# Term, Definition table Term Definition Rigid cystoscope An endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during cystoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. It is used to examine/diagnose incontinence, the inability to pass urine (retention), recurrent urinary tract infections, to remove tissue samples/stones/small tumours from the bladder, and for removal of the prostate. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 839138955 Device count 1 Premarket exempt true Lot or batch true Serial number true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04055207054390 NA Richard Wolf GmbH KQT 2026-05-19 06973356557754 Trious Shenzhen Trious Medical Technology Co., Ltd. KQT 2026-03-25 06973356557907 PUSEN Shenzhen Trious Medical Technology Co., Ltd. KQT 2025-12-08 04055207011911 NA Richard Wolf GmbH KQT 2024-08-19 00724995203306 BioVac US Endoscopy KQT 2020-11-23 10724995203303 BioVac US Endoscopy KQT 2020-11-23 00801741049057 Ellik Bladder Evacuator C. R. Bard, Inc. KQT 2020-09-22 00801741080647 Bladder Evacuator C. R. Bard, Inc. KQT 2020-09-22 00812261019413 Tur Vac ALLWIN MEDICAL DEVICES, INC. KQT 2020-09-22 00724995183783 BioVac US Endoscopy KQT 2020-04-01 00724995183790 BioVac US Endoscopy KQT 2020-04-01 00724995183806 BioVac US Endoscopy KQT 2020-04-01 10724995183780 BioVac US Endoscopy KQT 2020-04-01 10724995183797 BioVac US Endoscopy KQT 2020-04-01 10724995183803 BioVac US Endoscopy KQT 2020-04-01 00860002476100 Intussusception Air Reduction Kit with Blue tip GRI MEDICAL PRODUCTS INC KQT 2019-12-18 00860002476117 Intussusception Air Reduction Kit with Pink Tip GRI MEDICAL PRODUCTS INC KQT 2019-12-18 00860002476124 Intussusception Air Reduction kit, no tip GRI MEDICAL PRODUCTS INC KQT 2019-12-18 00860002476131 Intussusception Air Reduction Bulb & Gauge GRI MEDICAL PRODUCTS INC KQT 2019-12-18 00860002476148 Intussusception Air Reduction Bulb & Gauge with Plastic Case GRI MEDICAL PRODUCTS INC KQT 2019-12-18 00860002476155 Occlusion Disc GRI MEDICAL PRODUCTS INC KQT 2019-12-18 00860002476162 Intussusception Pressure Relief Valve GRI MEDICAL PRODUCTS INC KQT 2019-12-18 00841436104579 CollectEVAC CIVCO MEDICAL INSTRUMENTS CO., INC. KQT 2018-01-03 00841436108614 Cook CollectEVAC CIVCO MEDICAL INSTRUMENTS CO., INC. KQT 2018-01-03 00827002515499 Cook CollectEVAC CIVCO MEDICAL INSTRUMENTS CO., INC. KQT 2018-01-03 00848657016889 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. KQT 2017-11-28 00821925001053 Toomey Gyrus ACMI, LLC KQT 2016-10-11 00821925001077 Toomey Gyrus ACMI, LLC KQT 2016-10-11 00821925002593 Gyrus ACMI Gyrus ACMI, LLC KQT 2016-10-11 00821925003491 Gyrus ACMI Gyrus ACMI, LLC KQT 2016-10-11