Home GUDID D8063145BL0 Cool Breathe
Primary DI D8063145BL0
Brand Cool Breathe
Company MAYTEX CORPORATION
Model 3145BL
Device description Cool Breathe ear loop mask with middle bar
Published 2024-06-11
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 D8063145BL1 Primary HIBCC 0 D8063145BL0 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 designed to create an airtight seal against the user’s face, and typically includes ties/head straps; it might 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 false Serial number false Manufacturing date on label false 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 16980077680149 AOK AOK TOOLING LIMITED FXX 2026-06-04 16980077680156 AOK AOK TOOLING LIMITED FXX 2026-06-04 16980077680163 AOK AOK TOOLING LIMITED FXX 2026-06-04 16980077680101 AOK AOK TOOLING LIMITED FXX 2026-06-03 16980077680118 AOK AOK TOOLING LIMITED FXX 2026-06-03 16980077680125 AOK AOK TOOLING LIMITED FXX 2026-06-03 16980077680132 AOK AOK TOOLING LIMITED FXX 2026-06-03 16980077680071 AOK AOK TOOLING LIMITED FXX 2026-05-28 16980077680088 AOK AOK TOOLING LIMITED FXX 2026-05-28 16980077680095 AOK AOK TOOLING LIMITED FXX 2026-05-28 00681131106108 Equate WAL-MART STORES, INC. FXX 2026-02-25 00681131106092 Equate WAL-MART STORES, INC. FXX 2026-02-25 08809755250171 KP Protective Face Mask KP trading Co., Ltd. FXX 2026-02-19 10097604555514 Tronex International, Inc. TRONEX INTERNATIONAL, INC. FXX 2025-07-28 10371347011606 Advance Dental Products The Atlanta Dental Supply Company FXX 2024-03-01 10371347011613 Advance Dental Products The Atlanta Dental Supply Company FXX 2024-03-01 10371347011620 Advance Dental Products The Atlanta Dental Supply Company FXX 2024-03-01 10097604543320 Tronex International, Inc. TRONEX INTERNATIONAL, INC. FXX 2024-01-19 10097604553022 Tronex International, Inc. TRONEX INTERNATIONAL, INC. FXX 2024-01-19 10097604563229 Tronex International, Inc. TRONEX INTERNATIONAL, INC. FXX 2024-01-19 10097604573624 Tronex International, Inc. TRONEX INTERNATIONAL, INC. FXX 2024-01-19 10195327560522 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FXX 2023-12-21 10097604537022 Tronex International, Inc. TRONEX INTERNATIONAL, INC. FXX 2023-12-11 10097604538128 Tronex International, Inc. TRONEX INTERNATIONAL, INC. FXX 2023-12-11 10304040169022 Essentials HENRY SCHEIN, INC. FXX 2023-07-05 10304040169039 Essentials HENRY SCHEIN, INC. FXX 2023-07-05 10304040169046 Criterion HENRY SCHEIN, INC. FXX 2023-07-05 10304040165253 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040165260 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040168483 Criterion HENRY SCHEIN, INC. FXX 2023-06-26