Colonic Irrigation Nozzle

Basic Information

• Brand Name: Colonic Irrigation Nozzle
• Primary DI: B4247204000
• Version / Model: SP01 Large Bulb Speculum
• Catalog Number: 720400
• Company Name: CLEARWATER COLON HYDROTHERAPY, INC.
• Labeler DUNS: 942667882
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 806bb15e-c348-4493-ae06-18d6e5235e8f

Device Description

Large Bulb Speculum with Obturator, California Proposition 65 Material Compliant, Phthalates & DEHP Fee, CCH Part No. 720400

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPL	Colonic Irrigation System	Gastroenterology, Urology	876.5220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14187	Colonic lavage nozzle, single-use	A hollow cylinder intended to be inserted into the rectum for the administration of irrigation fluid from a connected colonic lavage system/unit; it may additionally be intended for use with an enema kit for the delivery of an enema solution. It is typically designed as a one-piece, moulded nozzle that may have a bulb shape at the distal end to improve retention in the rectum and a barbed fitting at the proximal end for the attachment of the irrigation/enema tubing. It may be designed for open (entry of fluid only) or closed (entry of fluid and evacuation of waste), and clinical or home-use, colonic lavage. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B424720400	HIBCC	Plastic Bag	1	In Commercial Distribution
Primary	B4247204000	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K000388	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Stored in Room Temperature