DeClogger

Basic Information

• Brand Name: DeClogger
• Primary DI: 00859911004405
• Version / Model: 935
• Catalog Number: 935
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2017-03-07
• Public Version: 7
• Public Version Date: 2023-11-22
• Public Version Status: Update
• Public Device Record Key: efa1193e-39c4-44a5-b246-e5d1d94c9b42

Device Description

DeClogger Starter Kit

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: Yes
• 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
KNT	TUBES, GASTROINTESTINAL (AND ACCESSORIES)	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58939	Enteral feeding tube clearing kit	A collection of non-sterile compounds and devices intended to be used to prevent and/or remove, through biochemical action, an enteral formula clog in an in situ enteral feeding tube to maintain luminal patency. It typically includes a combination of enzymes, acids, and buffers (e.g., papain, cellulase, citric acid) and devices (e.g., syringe, tubing) to administer the cocktail into the enteral feeding tube. This is a single-patient device that may be reapplied to the patient for a limited number of times (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859911004405	GS1
Unit of Use	10859911004402	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K905164	000