Home GUDID 00840039200565
RespoKare
Primary DI 00840039200565
Brand RespoKare
Company INNONIX TECHNOLOGIES LIMITED
Model RK-200-2001A-605C
Device description RespoKare Anti-viral Mask
Published 2021-02-25
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
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 00840039200626 Primary GS1 0 00840039200565 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 00840039200626 00840039200626 840039200626 0840039200626 00840039200565 00840039200565 840039200565 0840039200565
GMDN Terms# Term, Definition table Term Definition Surgical/medical respirator, antimicrobial A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large and small particles during medical, surgical, dental, and isolation procedures; it includes an antimicrobial/antiviral agent to destroy specified pathogens under specified contact conditions. It is typically made of multiple layers of non-woven polymers to produce a soft, flexible mask that will create an airtight seal against the user’s face and typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.
Regulatory Flags# DUNS number 680118887 Device count 5 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 80852212003715 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 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