LIBBE Colon Hydrotherapy System

Basic Information

• Brand Name: LIBBE Colon Hydrotherapy System
• Primary DI: 00868538000400
• Version / Model: 9703
• Company Name: Mind Body Naturopathic Inst
• Labeler DUNS: 929869659
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-29
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 6faf85b2-5b6b-4d9a-873d-7c8c5ec8cfea

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPL	Colonic Irrigation System	Gastroenterology, Urology	876.5220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43827	Colonic lavage system, gravity-flow	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00868538000400	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K941279	000