AccessGUDID - DEVICE: Colonic Lavage System (B4244001010)

GUDID

Device Identifier (DI) Information

Brand Name: Colonic Lavage System
Version or Model: PPC-101 Clinical
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 400101
Company Name: CLEARWATER COLON HYDROTHERAPY, INC.

Primary DI Number: B4244001010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 942667882 *Terms of Use

Device Description: PPC-101 Clinical Model/U.V. Filter System CCH Part No. 400101

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPL	Colonic Irrigation System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K942867	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Stored in Room Temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 19a8730d-4ac9-4082-96da-a20466121ad6
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016