Infusion Sets, Bien Air

Basic Information

• Brand Name: Infusion Sets, Bien Air
• Primary DI: J00715016350101
• Version / Model: 1501635-010
• Company Name: OMNIA SRL
• Labeler DUNS: 447696675
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2021-10-06
• Public Version: 1
• Public Version Date: 2021-10-14
• Public Version Status: New
• Public Device Record Key: c5a18ccd-6c03-45c9-84f8-02cf07618701

Device Description

Irrigation Line KM (10/pkg)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• PM Exempt: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EFS	Unit, Oral Irrigation	Dental	872.6510	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47890	Disposable surgical irrigation/aspiration system	A device assembly designed to irrigate, wash, and evacuate debris from general soft-tissue and orthopaedic surgical sites (e.g., for soft-tissue wound or bone debridement, site clearing, bone cement residue removal) with a pulsatile jet of sterile fluid (typically saline). It typically consists of a handpiece with an electrically-powered pump and irrigation/suction controls, tubing, and patient contact devices [typically detachable tips (applicators)] of various shapes and sizes for specific surgical applications. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	J00715016350011	HIBCC
Primary	J00715016350101	HIBCC