Home GUDID B959IFMSM30 Indiana Face Mask
Primary DI B959IFMSM30
Brand Indiana Face Mask
Company Fssc LLC
Model IFM-SM3
Device description ASTM Level 3 Surgical Mask
Published 2022-07-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name FXX Mask, Surgical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FXX Mask, Surgical General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B959IFMSM31 Package HIBCC 10 In Commercial Distribution B959IFMSM30 Primary HIBCC 0 B959IFMSM300 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Surgical/medical face mask, non-antimicrobial, single-use A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.
Regulatory Flags# DUNS number 117675515 Device count 50 DM exempt true Lot or batch true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B959IFMSM31 Indiana Face Mask IFM-SM3 2022-07-01
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