AccessGUDID - DEVICE: Colonic Lavage Unit (B482HC2000C0)

GUDID

Device Identifier (DI) Information

Brand Name: Colonic Lavage Unit
Version or Model: HC-2000 Classic
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HC-2000 Classic
Company Name: TRANSCENDENCIAS COMERCIALES SL

Primary DI Number: B482HC2000C0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 562820084 *Terms of Use

Device Description: Colonic Hydroteraphy machine designed for semi-automatic irrigation, washing, and evacuation of debris from the colon. Consists of an electromechanical unit that irrigates sterilised water into the patient´s colon. Flow, pressure and temperature can be regulated from a pressurized water supply (i.e., tap water), and contains pressure and temperature controls. It is a wall fixed, non-portable machine.

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):	No
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?
58181	Colonic lavage unit	A mains electricity (AC-powered) device designed for semi-automated irrigation, washing, and evacuation of debris from the colon (e.g., faeces, mucous, old cells) primarily for therapeutic applications (e.g., chronic constipation). It consists of an electromechanical unit that regulates flow from a pressurized water supply (i.e., tap water), and typically contains water heating elements, temperature controls, and an operating display. It is connected to a tube that is placed in the patient's rectum enabling warm water to irrigate the colon; it is not designed for automated removal of waste (i.e., open system). It is intended to be operated by a healthcare provider in a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPL	Colonic Irrigation System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K970482	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3f1f6616-9fea-4c0b-a6f0-4ceaa00aa496
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 29, 2016