Oxygen Filter

Basic Information

• Brand Name: Oxygen Filter
• Primary DI: 00848530105419
• Version / Model: BF5003
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-15
• Public Version: 2
• Public Version Date: 2025-04-25
• Public Version Status: Update
• Public Device Record Key: 2898e562-0e01-419d-8955-50a71ebf8495

Device Description

Nidek Nuvo Lite Style Inlet 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: No
• 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
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	868.5260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64966	Respirator filter/cartridge, particulates	A device designed be attached to a respirator mask body to filter large particles (e.g., blood, body fluids, and airborne particulate materials) and small particles (e.g., bacteria and viruses). Filtration occurs in both directions and is achieved with electrostatically charged fibres. This is a reusable device, typically with a limited lifetime.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848530105419	GS1
Package	10848530105416	GS1	Case	100	In Commercial Distribution

Customer Contacts

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