Home GUDID D8063135BL0 Maytex
Primary DI D8063135BL0
Brand Maytex
Company MAYTEX CORPORATION
Model 3135BL
Device description Ear loop mask
Published 2022-08-22
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 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 D8063135BL1 Primary HIBCC 0 D8063135BL0 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Surgical/medical respirator, non-antimicrobial, single-use 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 particles (e.g., body fluids, airborne particulate materials) and small particles (e.g., bacteria) during medical, surgical, dental, and isolation procedures; it does not include an antimicrobial agent(s). 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 196642151 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 true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 00850054870704 BAYLAB USA Baylab USA, LLC FXX 2026-10-01 G539MM3S1 Saf-T-Gard Saf-T-Gard International, Inc. FXX 2026-09-21 G539MM3S2 Saf-T-Gard Saf-T-Gard International, Inc. FXX 2026-09-21 G539MM3SB1 Saf-T-Gard Saf-T-Gard International, Inc. FXX 2026-09-21 G539MM3SB2 Saf-T-Gard Saf-T-Gard International, Inc. FXX 2026-09-21 00050428143315 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED FXX 2026-09-18 00050428340561 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED FXX 2026-09-18 10304040195472 Essentials HENRY SCHEIN, INC. FXX 2026-09-04 10304040195489 Essentials HENRY SCHEIN, INC. FXX 2026-09-04 00810194402623 Aira AIRA, LLC FXX 2026-08-26 20197344219237 MEDLINE MEDLINE INDUSTRIES, INC. FXX 2026-07-31 06974960061330 S&J Xiantao S&J Protective Products Co., Ltd FXX 2026-07-29 00840456202814 JMU JMU DENTAL, INC FXX 2026-07-24 00840456202807 JMU JMU DENTAL, INC FXX 2026-07-23 00840456214664 JMU JMU DENTAL, INC FXX 2026-07-23 00840456214671 JMU JMU DENTAL, INC FXX 2026-07-23 00840456214688 JMU JMU DENTAL, INC FXX 2026-07-23 00840456214695 JMU JMU DENTAL, INC FXX 2026-07-23 30197344201697 MEDLINE MEDLINE INDUSTRIES, INC. FXX 2026-07-20 00810145950975 NeuMask Pink Medgluv Inc. FXX 2026-07-17 00850005229728 NeuMask Orange Medgluv Inc. FXX 2026-07-17 00850086117037 Resilient Medical Solutions Resilient Medical Solutions, LLC FXX 2026-07-08 00840456202722 JMU JMU DENTAL, INC FXX 2026-07-07 00840456202739 JMU JMU DENTAL, INC FXX 2026-07-07 00840456202746 JMU JMU DENTAL, INC FXX 2026-07-07 00840456214619 JMU JMU DENTAL, INC FXX 2026-07-07 00840456214626 JMU JMU DENTAL, INC FXX 2026-07-07 00840456214633 JMU JMU DENTAL, INC FXX 2026-07-07 00840456214640 JMU JMU DENTAL, INC FXX 2026-07-07 00840456214657 JMU JMU DENTAL, INC FXX 2026-07-07