LIBBE Colonic Nozzle

Basic Information

• Brand Name: LIBBE Colonic Nozzle
• Primary DI: 00868538000417
• Version / Model: 298-8888
• Company Name: Mind Body Naturopathic Inst
• Labeler DUNS: 929869659
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-30
• Public Version: 1
• Public Version Date: 2021-05-10
• Public Version Status: New
• Public Device Record Key: 515c8cb9-faaf-49e6-8c03-dc57ddedaf24

Device Description

One-piece, smooth body, molded, tube shaped, medical grade plastic accessory that is for colon cleansing when medically indicated, such as before radiological or endoscopic examination.

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: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
48009	Colonic lavage nozzle, sterile	A sterile, hollow cylinder intended to be inserted into the rectum for the administration of irrigation fluid from a connected colonic lavage system or a colonic irrigation unit. It is typically designed as a one-piece, moulded nozzle that may have a slight 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 fluid 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	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10868538000414	GS1	Box	50	In Commercial Distribution
Primary	00868538000417	GS1

Customer Contacts

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