Home GUDID B482Z090 Colonic Irrigation Kit
Primary DI B482Z090
Brand Colonic Irrigation Kit
Company TRANSCENDENCIAS COMERCIALES SL
Model Large Hydrokit
Catalog number Z-09
Device description Colon Hydrotherapy Disposable Single-Use Kit, consisting of a large size Bulb Style Speculum with Obturator, a water inflow tube, a collapsible waste hose and a 2.5 g sachet of lubricant.
Published 2016-12-29
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name KPL Colonic Irrigation System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KPL Colonic Irrigation System Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B482Z091 Package HIBCC 75 In Commercial Distribution B482Z092 Package HIBCC 100 In Commercial Distribution B482Z090 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Colonic lavage kit, non-surgical A collection of non-sterile devices intended to be used with a colonic lavage system/unit for the administration of an irrigation solution (e.g., saline solution) via the rectum, for the non-surgical irrigation, cleansing, and evacuation of debris from the colon. It includes both an inflow tube (intended to facilitate the ingress of fluid into the colon) and a waste tube (intended to transport fluids and waste matter away from the patient), a colonic irrigation nozzle, and may include additional supportive devices (e.g., lubricant, connectors). The kit may also be intended to support enema delivery. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Avoid sunlight Special Storage Condition, Specify 0 0 Keep Dry Storage Environment Temperature 0 Degrees Celsius 35 Degrees Celsius
Regulatory Flags# DUNS number 562820084 Device count 1 Kit true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B482Z100 Colonic irrigation Kit Small Hydrokit Z-10 2016-12-29 B482Z160 Colonic Irrigation Kit Segmented Hose / Hydrokit with limiter Z-16 2016-12-29 B482Z200 Colonic Irrigation Kit Segmented Hose / Large Hydrokit Z-20 2016-12-29 B482Z170 Colonic Irrigation Kit Hydrokit with limiter Z-17 2016-12-29 B482Z091 Colonic Irrigation Kit Large Hydrokit Z-09 2016-12-29 B482Z101 Colonic irrigation Kit Small Hydrokit Z-10 2016-12-29 B482Z161 Colonic Irrigation Kit Segmented Hose / Hydrokit with limiter Z-16 2016-12-29 B482Z171 Colonic Irrigation Kit Hydrokit with limiter Z-17 2016-12-29 B482Z201 Colonic Irrigation Kit Segmented Hose / Large Hydrokit Z-20 2016-12-29 B482HC10 Colonic Lavage Unit HC-1 HC-1 2016-12-29 B482HC1C0 Colonic Lavage Unit HC-1 Classic HC-1 Classic 2016-12-29 B482HC2000C0 Colonic Lavage Unit HC-2000 Classic HC-2000 Classic 2016-12-29 B482HC11 Colonic Lavage Unit HC-1 HC-1 2016-12-29 B482HC1C1 Colonic Lavage Unit HC-1 Classic HC-1 Classic 2016-12-29 B482HC2000C1 Colonic Lavage Unit HC-2000 Classic HC-2000 Classic 2016-12-29
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B149CM11 Angel of Water LIFESTREAM PURIFICATION SYSTEM LLC KPL 2023-12-11 00868538000417 LIBBE Colonic Nozzle Mind Body Naturopathic Inst KPL 2021-04-30 10868538000414 LIBBE Colonic Nozzle Mind Body Naturopathic Inst KPL 2021-04-30 00850014947163 QMS - AQUA CLEANSE QUALITY MEDICAL SUPPLY, INC. KPL 2019-12-12 00868538000400 LIBBE Colon Hydrotherapy System Mind Body Naturopathic Inst KPL 2017-12-29 B149SP0001 Colon Cleansing Nozzle with Flex Tube LIFESTREAM PURIFICATION SYSTEM LLC KPL 2017-02-10 B149SP00011 Colon Cleansing Nozzle with Flex Tube LIFESTREAM PURIFICATION SYSTEM LLC KPL 2017-02-10 B482HC10 Colonic Lavage Unit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482HC1C0 Colonic Lavage Unit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482HC2000C0 Colonic Lavage Unit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482Z100 Colonic irrigation Kit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482Z160 Colonic Irrigation Kit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482Z170 Colonic Irrigation Kit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482Z200 Colonic Irrigation Kit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482HC11 Colonic Lavage Unit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482HC1C1 Colonic Lavage Unit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482HC2000C1 Colonic Lavage Unit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482Z091 Colonic Irrigation Kit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482Z101 Colonic irrigation Kit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482Z161 Colonic Irrigation Kit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482Z171 Colonic Irrigation Kit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482Z201 Colonic Irrigation Kit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B4244001010 Colonic Lavage System CLEARWATER COLON HYDROTHERAPY, INC. KPL 2016-09-24 B4244001510 Colonic Lavage System CLEARWATER COLON HYDROTHERAPY, INC. KPL 2016-09-24 B4244002010 Colonic Lavage System CLEARWATER COLON HYDROTHERAPY, INC. KPL 2016-09-24 B4247201000 Colonic Irrigation Nozzle CLEARWATER COLON HYDROTHERAPY, INC. KPL 2016-09-24 B4247202000 Colonic Irrigation Nozzle CLEARWATER COLON HYDROTHERAPY, INC. KPL 2016-09-24 B4247203000 Colonic Irrigation Nozzle CLEARWATER COLON HYDROTHERAPY, INC. KPL 2016-09-24 B4247204000 Colonic Irrigation Nozzle CLEARWATER COLON HYDROTHERAPY, INC. KPL 2016-09-24 B4249214420 Colonic Irrigation Kit CLEARWATER COLON HYDROTHERAPY, INC. KPL 2016-09-24