LIBBE Colon Hydrotherapy System

Primary DI
00868538000400
Brand
LIBBE Colon Hydrotherapy System
Company
Mind Body Naturopathic Inst
Model
9703
Device description
The LIBBE System is designed to allow evacuation of the contents of the colon during the administration of the colonic irrigation. The pressure, temperature, and flow of water can all be safely regulated throughout the procedure. The Seat Base is designed to allow both Colon and Bladder to release as client/patient desires.
Published
2017-12-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K941279000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941279000LOWER BOWEL EVACUATION SYSTEMTiller Mind Body, Inc.1995-10-12KPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868538000400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868538000400008685380004008685380004000868538000400

GMDN Terms#

Term, Definition table
TermDefinition
Colonic lavage system, gravity-flowAn assembly of devices designed for the irrigation, washing, and evacuation of debris from the colon. It typically consists of a fluid reservoir, tubing, nozzle, and controls that regulate the temperature and pressure of the gravity-induced water flow from a tap (faucet) and into the rectum. The device may include a console-type toilet and fittings to allow connection to water and sewer pipes for the effluent. The system provides colonic hydrotherapy to remove damaged tissue and/or debris (e.g., faeces, foreign objects) in emergency departments, and to clean/evacuate the colon for endoscopic/surgical procedures.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(210)308-8888qc@colonic.net

Regulatory Flags#

DUNS number
929869659
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00868538000417LIBBE Colonic Nozzle298-88882021-04-30
10868538000414LIBBE Colonic Nozzle298-88882021-04-30

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
B149SP0001Colon Cleansing Nozzle with Flex TubeLIFESTREAM PURIFICATION SYSTEM LLCKPL2017-02-10
B149SP00011Colon Cleansing Nozzle with Flex TubeLIFESTREAM PURIFICATION SYSTEM LLCKPL2017-02-10
B482HC10Colonic Lavage UnitTRANSCENDENCIAS COMERCIALES SLKPL2016-12-29
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