Identity
- Trade Name
- LIBBE Colon Hydrotherapy System FDA UDI
- Generic Name
- Colonic lavage system, gravity-flow FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 9703 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00868538000400 FDA UDI
- 510(k) Number
- K941279 FDA UDI
- FDA Product Code
- KPL FDA UDI
- GMDN Term
- Colonic lavage system, gravity-flow FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5220 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Colonic lavage system, gravity-flow
LIBBE Colon Hydrotherapy System by Mind Body Naturopathic Inst — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Colonic lavage system, gravity-flow.
- Colonic Lavage System — CLEARWATER COLON HYDROTHERAPY, INC. · Class II
- Angel of Water — LIFESTREAM PURIFICATION SYSTEM LLC · Class II
- Aquanet — Prime Pacific Health Innovations Corporation · Class II
- Colonic Lavage System — CLEARWATER COLON HYDROTHERAPY, INC. · Class II
- Colonic Lavage System — CLEARWATER COLON HYDROTHERAPY, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Mind Body Naturopathic Inst
Sources (1)
- FDA UDI 6faf85b2-5b6b-4d9a-873d-7c8c5ec8cfea 35 fields · synced May 30, 2026