Home GUDID 80852212003715 ProGear/Oxafence
Primary DI 80852212003715
Brand ProGear/Oxafence
Company PRESTIGE AMERITECH, LTD.
Model AV82030
Device description Antiviral Earloop Mask, ASTM Level 3
Published 2024-10-21
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx false
OTC true
Sterile false
Single use true Product Codes# Code, Name table Code Name OUK Surgical Mask With Antimicrobial/Antiviral Agent
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OUK Surgical Mask With Antimicrobial/Antiviral Agent General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20852212003713 Package GS1 10 In Commercial Distribution 00852212003719 Primary GS1 0 80852212003715 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 20852212003713 20852212003713 00852212003719 00852212003719 852212003719 0852212003719 80852212003715 80852212003715
GMDN Terms# Term, Definition table Term Definition Surgical/medical face mask, 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 includes an antimicrobial/antiviral agent to prevent/inhibit the proliferation of microbes under specified conditions 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 199692794 Device count 50 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 40852212003717 ProGear/Oxafence PRESTIGE AMERITECH, LTD. OUK 2025-08-05 50852212003714 ProGear/Oxafence PRESTIGE AMERITECH, LTD. OUK 2025-08-05 10852212003716 ProGear/Oxafence PRESTIGE AMERITECH, LTD. OUK 2025-01-13 30852212003710 ProGear/Oxafence PRESTIGE AMERITECH, LTD. OUK 2025-01-13 00852212003719 ProGear/Oxafence PRESTIGE AMERITECH, LTD. OUK 2024-10-21 00840039200640 RespoKare INNONIX TECHNOLOGIES LIMITED OUK 2021-08-10 00888277359867 Curad MEDLINE INDUSTRIES, INC. OUK 2021-04-15 40888277359865 Curad MEDLINE INDUSTRIES, INC. OUK 2021-04-15 00860006561826 Cufitec Surgical Mask NBC MESHTEC INC. OUK 2021-03-31 00888277359850 MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC. OUK 2021-03-16 00840039200626 RespoKare INNONIX TECHNOLOGIES LIMITED OUK 2021-02-25 00840039200565 RespoKare INNONIX TECHNOLOGIES LIMITED OUK 2021-02-25 00840039200558 RespoKare INNONIX TECHNOLOGIES LIMITED OUK 2021-01-22 00840039200015 RespoKare INNONIX TECHNOLOGIES LIMITED OUK 2021-01-13 00840039200527 RespoKare INNONIX TECHNOLOGIES LIMITED OUK 2021-01-13 00840039200213 RespoKare INNONIX TECHNOLOGIES LIMITED OUK 2021-01-13 00708820228818 Meijer MEIJER, INC. OUK 2018-12-28 10884389129814 Medline MEDLINE INDUSTRIES, INC. OUK 2016-10-14 10884389148020 Medline MEDLINE INDUSTRIES, INC. OUK 2016-10-14 30884389129818 Medline MEDLINE INDUSTRIES, INC. OUK 2016-10-14
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