AlphaCleanse® Antimicrobial Wound Care System

Basic Information

• Brand Name: AlphaCleanse® Antimicrobial Wound Care System
• Primary DI: 00714646000804
• Version / Model: WI-5750
• Catalog Number: 5750
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-18
• Public Version: 5
• Public Version Date: 2024-01-08
• Public Version Status: Update
• Public Device Record Key: b12e2884-eb0b-47f2-8d7c-28e19af1808b
• Distribution End Date: 2024-01-03

Device Description

AlphaCleanse® Antimicrobial Wound Care System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FQH	LAVAGE, JET	General Hospital	880.5475	2

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	00714646000804	GS1

Customer Contacts

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