BIONIX DEVELOPMENT CORPORATION

Basic Information

• Brand Name: BIONIX DEVELOPMENT CORPORATION
• Primary DI: 00859911004399
• Version / Model: 5100
• Catalog Number: 5100
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2017-03-06
• Public Version: 7
• Public Version Date: 2023-09-29
• Public Version Status: Update
• Public Device Record Key: 51b5ef9a-f1cd-4ae9-8460-c44df8d9f2bb
• Distribution End Date: 2023-08-31

Device Description

Wound Irrigation System

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: Yes
• 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
KYZ	SYRINGE, IRRIGATING (NON DENTAL)	General Hospital	880.6960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
14462	Wound irrigation kit	A collection of noninvasive devices intended to be used by a healthcare professional to irrigate/cleanse an acute, chronic, or surgical wound. It consists of multiple items which typically include an irrigation instrument (e.g., syringe, bulb), wipes, towel, drape and/or irrigation solution. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859911004399	GS1
Unit of Use	10859911004396	GS1

Customer Contacts

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