Home GUDID 00850048720688 Colonic Irrigation System
Primary DI 00850048720688
Brand Colonic Irrigation System
Company Specialty Health Products, LLC
Model Hydro-San Plus
Published 2026-07-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false 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 00850048720688 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 00850048720688 00850048720688 850048720688 0850048720688
GMDN Terms# Term, Definition table Term Definition Colonic lavage unit A mains electricity (AC-powered) device designed for semi-automated irrigation, washing, and evacuation of debris from the colon (e.g., faeces, mucous, old cells) primarily for therapeutic applications (e.g., chronic constipation). It consists of an electromechanical unit that regulates flow from a pressurized water supply (i.e., tap water), and typically contains water heating elements, temperature controls, and an operating display. It is connected to a tube that is placed in the patient's rectum enabling warm water to irrigate the colon; it is not designed for automated removal of waste (i.e., open system). It is intended to be operated by a healthcare provider in a clinical setting.
Regulatory Flags# DUNS number 119446468 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# 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 B482Z090 Colonic Irrigation Kit 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