SafetyFilta

Basic Information

• Brand Name: SafetyFilta
• Primary DI: 20817494020254
• Version / Model: GRO-SF-NEB-25
• Catalog Number: GRO-SF-NEB-25
• Company Name: GROMAN INC.
• Labeler DUNS: 020124663
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2023-01-19
• Public Version: 1
• Public Version Date: 2023-01-27
• Public Version Status: New
• Public Device Record Key: 118143b0-f92c-469f-b706-97b133be991c
• Distribution End Date: 2053-01-19

Device Description

Stick-on Filter for Vented Respiratory Masks to achieve Aerosol Reduction

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: Yes
• MRI Safety: MR Safe
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYX	Tubing, Pressure And Accessories	Anesthesiology	868.5860	1

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
Unit of Use	00817494020250	GS1
Primary	20817494020254	GS1