Colonic Lavage Unit

Primary DI
B482HC10
Brand
Colonic Lavage Unit
Company
TRANSCENDENCIAS COMERCIALES SL
Model
HC-1
Catalog number
HC-1
Device description
Colonic Hydroteraphy machine designed for manual irrigation, washing, and evacuation of debris from the colon. Consists of an electromechanical unit that irrigates sterilised water into the patient´s colon. Flow, pressure and temperature can be regulated from a pressurized water supply (i.e., tap water), and contains pressure and temperature controls. It is a portable machine.
Published
2016-12-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KPLColonic Irrigation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPLColonic Irrigation SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131852000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131852000HC-1 AND HC-1 CLASSICTranscendencias Comerciales SL Transcom2014-04-17KPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B482HC11PackageHIBCC1In Commercial Distribution
B482HC10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Colonic lavage unitA 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
562820084
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B482Z090Colonic Irrigation KitLarge HydrokitZ-092016-12-29
B482Z100Colonic irrigation KitSmall HydrokitZ-102016-12-29
B482Z160Colonic Irrigation KitSegmented Hose / Hydrokit with limiterZ-162016-12-29
B482Z200Colonic Irrigation KitSegmented Hose / Large HydrokitZ-202016-12-29
B482Z170Colonic Irrigation KitHydrokit with limiterZ-172016-12-29
B482Z091Colonic Irrigation KitLarge HydrokitZ-092016-12-29
B482Z101Colonic irrigation KitSmall HydrokitZ-102016-12-29
B482Z161Colonic Irrigation KitSegmented Hose / Hydrokit with limiterZ-162016-12-29
B482Z171Colonic Irrigation KitHydrokit with limiterZ-172016-12-29
B482Z201Colonic Irrigation KitSegmented Hose / Large HydrokitZ-202016-12-29
B482HC1C0Colonic Lavage UnitHC-1 ClassicHC-1 Classic2016-12-29
B482HC2000C0Colonic Lavage UnitHC-2000 ClassicHC-2000 Classic2016-12-29
B482HC11Colonic Lavage UnitHC-1HC-12016-12-29
B482HC1C1Colonic Lavage UnitHC-1 ClassicHC-1 Classic2016-12-29
B482HC2000C1Colonic Lavage UnitHC-2000 ClassicHC-2000 Classic2016-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B149CM11Angel of WaterLIFESTREAM PURIFICATION SYSTEM LLCKPL2023-12-11
00868538000417LIBBE Colonic NozzleMind Body Naturopathic InstKPL2021-04-30
10868538000414LIBBE Colonic NozzleMind Body Naturopathic InstKPL2021-04-30
00850014947163QMS - AQUA CLEANSEQUALITY MEDICAL SUPPLY, INC.KPL2019-12-12
00868538000400LIBBE Colon Hydrotherapy SystemMind Body Naturopathic InstKPL2017-12-29
B149SP0001Colon Cleansing Nozzle with Flex TubeLIFESTREAM PURIFICATION SYSTEM LLCKPL2017-02-10
B149SP00011Colon Cleansing Nozzle with Flex TubeLIFESTREAM PURIFICATION SYSTEM LLCKPL2017-02-10
B482HC1C0Colonic Lavage UnitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482HC2000C0Colonic Lavage UnitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482Z090Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482Z100Colonic irrigation KitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482Z160Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482Z170Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482Z200Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482HC11Colonic Lavage UnitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482HC1C1Colonic Lavage UnitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482HC2000C1Colonic Lavage UnitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482Z091Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482Z101Colonic irrigation KitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482Z161Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482Z171Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B482Z201Colonic Irrigation KitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
B4244001010Colonic Lavage System CLEARWATER COLON HYDROTHERAPY, INC.KPL2016-09-24
B4244001510Colonic Lavage SystemCLEARWATER COLON HYDROTHERAPY, INC.KPL2016-09-24
B4244002010Colonic Lavage System CLEARWATER COLON HYDROTHERAPY, INC.KPL2016-09-24
B4247201000Colonic Irrigation NozzleCLEARWATER COLON HYDROTHERAPY, INC.KPL2016-09-24
B4247202000Colonic Irrigation NozzleCLEARWATER COLON HYDROTHERAPY, INC.KPL2016-09-24
B4247203000Colonic Irrigation NozzleCLEARWATER COLON HYDROTHERAPY, INC.KPL2016-09-24
B4247204000Colonic Irrigation NozzleCLEARWATER COLON HYDROTHERAPY, INC.KPL2016-09-24
B4249214420Colonic Irrigation KitCLEARWATER COLON HYDROTHERAPY, INC.KPL2016-09-24