3B RESmart Style Filters

Basic Information

• Brand Name: 3B RESmart Style Filters
• Primary DI: 00848530036010
• Version / Model: CF8004
• Catalog Number: CF8004
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2018-06-04
• Public Version: 1
• Public Version Date: 2018-07-05
• Public Version Status: New
• Public Device Record Key: bd9553ab-f9c4-4d51-84aa-77357cdc8622

Device Description

3B RESmart Style Filters (3/pack)

Device Characteristics

• Single Use: No
• 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
JRL	Unit, Filter, Membrane	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63172	CPAP/BPAP unit ambient air filter, reusable	A non-sterile filter designed to be installed in a continuous positive airway pressure (CPAP) and/or bi-level positive airway pressure (BPAP) unit to filter particulates from the ambient air prior to inhalation; it is not intended to filter medical gases. It is typically a flat sheet or pad composed of tightly woven materials or foam intended to be installed over the air inlet of the CPAP/BPAP device to remove particulates/impurities; it is not intended to filter microbes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848530036010	GS1
Unit of Use	10848530036017	GS1

Customer Contacts

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