Bionix Development Corporation

Basic Information

• Brand Name: Bionix Development Corporation
• Primary DI: 00859911004184
• Version / Model: 3700
• Catalog Number: 3700
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2017-01-28
• Public Version: 5
• Public Version Date: 2023-07-18
• Public Version Status: Update
• Public Device Record Key: 46583aec-597f-4c5a-bef8-441e1ed127c8

Device Description

Box of 3 Ear Basins

Device Characteristics

• Single Use: No
• 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
FNY	BASIN, EMESIS	General Hospital	880.6730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42893	General-purpose bowl, reusable	A portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary including round, oblong, deep or quite shallow. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859911004184	GS1
Unit of Use	10859911004181	GS1

Customer Contacts

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