Illuvia

Basic Information

• Brand Name: Illuvia
• Primary DI: 00852348007896
• Version / Model: Illuvia HEPA Filter
• Company Name: AEROBIOTIX, INC.
• Labeler DUNS: 046659903
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-03
• Public Version: 1
• Public Version Date: 2021-12-13
• Public Version Status: New
• Public Device Record Key: 11d4136f-f353-4c87-8732-e279f5a0e2ff

Device Description

Air purification HEPA filter

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FZH	Apparatus, Air Handling, Room	General, Plastic Surgery	878.5070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36138	Surgical laminar airflow unit	An electrically-powered device designed to filter air [usually through a high-efficiency particulate air (HEPA) filter] in surgical theatres by producing a directed, non-turbulent flow of clean air to provide an area free of contaminants and reduce the risk of patient infection. It may be mobile (on wheels) or fixed [e.g., to the ceiling], and provides a curtain of fast moving air that helps to delineate the sterile field; some types allow connection of a hose with a nozzle designed to be adhered to the patient to direct the filtered air across the surgical site. An operating light or light system may be mounted to this unit.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852348007896	GS1

Customer Contacts

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