Oxygen Filter

Basic Information

• Brand Name: Oxygen Filter
• Primary DI: 00848530051150
• Version / Model: OF8002SP-PL
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-19
• Public Version: 2
• Public Version Date: 2026-01-12
• Public Version Status: Update
• Public Device Record Key: 6cf08f87-1cc3-4f83-9f7c-0e7eb7443364

Device Description

Airsep Kit This kit contains: 2- OF8002, 1- OF8001, 1- BF1438

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
JRL	Unit, Filter, Membrane	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31245	Local/regional anaesthesia conduction filter	A microporous membrane used to minimize particulate (foreign material) contamination of a local anaesthetic during subcutaneous administration to a patient (e.g., through a spinal or epidural catheter); it may in addition be intended for use during medication administration or preparation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848530051150	GS1

Customer Contacts

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