LIBBE Colon Hydrotherapy System

GUDID 00868538000400

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.

Mind Body Naturopathic Inst

Colonic lavage system, gravity-flow

• Primary Device ID: 00868538000400
• NIH Device Record Key: 6faf85b2-5b6b-4d9a-873d-7c8c5ec8cfea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIBBE Colon Hydrotherapy System
• Version Model Number: 9703
• Company DUNS: 929869659
• Company Name: Mind Body Naturopathic Inst
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (210)308-8888
• Email: qc@colonic.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868538000400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941279

FDA Product Code

• KPL: Colonic Irrigation System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-29

Devices Manufactured by Mind Body Naturopathic Inst

• 10868538000414 - LIBBE Colonic Nozzle: 2021-05-10 One-piece, smooth body, molded, tube shaped, medical grade plastic accessory that is for colon cleansing when medically indicate
• 00868538000400 - LIBBE Colon Hydrotherapy System: 2018-07-06The 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.
• 00868538000400 - LIBBE Colon Hydrotherapy System: 2018-07-06 The LIBBE System is designed to allow evacuation of the contents of the colon during the administration of the colonic irrigatio