Colonic Lavage System

FDA UDI

Class II (US FDA UDI)

by Clearwater Colon Hydrotherapy, Inc.

Identity

Trade Name: Colonic Lavage System FDA UDI
Generic Name: Colonic lavage system, gravity-flow FDA UDI
Device Name: PPC-101 Clinical Model/U.V. Filter System (Specimen Collector) CCH Part No. 400151 FDA UDI
Model / Reference: PPC-101 Clinical Specimen Collector FDA UDI
Description: PPC-101 Clinical Model/U.V. Filter System (Specimen Collector) CCH Part No. 400151 FDA UDI

Identifiers

Catalog Number: 400151 FDA UDI
Primary DI / UDI-DI: B4244001510 FDA UDI
510(k) Number: K942867 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Colonic lavage system, gravity-flow

Colonic Lavage System by Clearwater Colon Hydrotherapy, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Colonic lavage system, gravity-flow.

Angel of Water — LIFESTREAM PURIFICATION SYSTEM LLC · Class II
Aquanet — Prime Pacific Health Innovations Corporation · Class II
LIBBE Colon Hydrotherapy System — Mind Body Naturopathic Inst · Class II
Colonic Lavage System — CLEARWATER COLON HYDROTHERAPY, INC. · Class II
Colonic Lavage System — CLEARWATER COLON HYDROTHERAPY, INC. · Class II

Cleared under the same submission

K942867 also covers:

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: Clearwater Colon Hydrotherapy, Inc.

Sources (1)

FDA UDI 904eeb41-f8a9-4ecd-9348-4d71e4b031dc 37 fields · synced May 30, 2026