AccessGUDID - DEVICE: Colonic Irrigation Nozzle (B4247202000)

GUDID

Device Identifier (DI) Information

Brand Name: Colonic Irrigation Nozzle
Version or Model: SP02 Small Bulb Speculum
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 720200
Company Name: CLEARWATER COLON HYDROTHERAPY, INC.

Primary DI Number: B4247202000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 942667882 *Terms of Use

Device Description: Small Bulb Speculum with Obturator, California Proposition 65 Material Compliant, Phthalates & DEHP Fee, CCH Part No. 720200

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:	Yes
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?
14187	Rectal/colonic irrigation nozzle, single-use	An invasive luminal device intended to be inserted into the rectum and/or colostomy site for the administration of irrigation fluid into the rectum and/or large intestines during a rectal irrigation, colonic lavage, enema, and/or colostomy site irrigation procedure. Available in a variety of designs, it may be referred to as a cone, tip, speculum, or rectal catheter, and may include an inflatable balloon for retention. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPL	Colonic Irrigation System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K000388	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: f40291ce-b195-46fd-bc69-f65927d09b15
Public Version Date: June 19, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016