Home GUDID 00604351600508 AE II BAN
Primary DI 00604351600508
Brand AE II BAN
Company Monaghan Medical Corporation
Model Filtered Mouthpiece, cs/50
Published 2017-07-25
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true Product Codes# Code, Name table Code Name BYW Device, Rebreathing
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BYW Device, Rebreathing Anesthesiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 50604351600503 Package GS1 50 Not in Commercial Distribution 00604351600508 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 50604351600503 50604351600503 00604351600508 00604351600508 604351600508 0604351600508
GMDN Terms# Term, Definition table Term Definition Breathing mouthpiece, reusable A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. The device accepts or attaches to, either directly or through other tubes/adapters, diagnostic/therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser). Some types generate a whistling sound to guide effective inhalation [e.g., during use of a metered dose inhaler (MDI)]. This is a reusable device which may be intended for single- or multi-patient use.
Regulatory Flags# DUNS number 056332380 Device count 1 Premarket 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 00604351673106 MC 300 Reusable Nebulizer MC300 2026-05-26 00604351506121 Aerochamber2go Anti-Static Valved Holding Chamber AeroChamber2go, cs/12 2025-05-30 00604351505124 Aerobika,OPEP Aerobika, OPEP Device, Retail 2024-05-16 00604351707061 Nasoneb® NasoNeb Sinus Therapy System cs/6 2024-10-25 50604351707066 Nasoneb® NasoNeb Sinus Therapy System cs/6 2024-10-25 50604351505129 Aerobika,OPEP Aerobika, OPEP Device, Retail 2024-05-16 00604351350014 Nasoneb® NasoNeb Compressor 2024-04-09 00604351504127 Aerochamber Plus® Flow-Vu® aVHC, Intermediate Mask, cs/12 2024-03-01 50604351504122 Aerochamber Plus® Flow-Vu® aVHC, Intermediate Mask, cs/12 2024-03-01 00604351501126 Aerochamber Plus® Flow-Vu® aVHC, Small Mask, cs/12 2023-11-14 00604351502123 Aerochamber Plus® Flow-Vu® aVHC, Medium Mask, cs/12 2023-11-14 00604351503120 Aerochamber Plus® Flow-Vu® aVHC, Large Mask, cs/12 2023-11-14 00604351500129 Aerochamber Plus® Flow-Vu® aVHC, Mouthpiece, cs/12 2023-11-14 50604351501121 Aerochamber Plus® Flow-Vu® aVHC, Small Mask, cs/12 2023-11-14 50604351502128 Aerochamber Plus® Flow-Vu® aVHC, Medium Mask, cs/12 2023-11-14 50604351503125 Aerochamber Plus® Flow-Vu® aVHC, Large Mask, cs/12 2023-11-14 00604351886858 Monaghan Kit, Educational, MMC Z STAT™ aVHC 88685 2018-10-12 00604351788015 Aerochamber Plus® Flow-Vu® aVHC, Medium Mask, NFR, Single 2016-10-10 00604351798014 Aerochamber Plus® Flow-Vu® aVHC, Mouthpiece, NFR, Single 2016-10-10 00604351808010 Aerochamber Plus® Flow-Vu® aVHC, Large Mask, NFR, Single 2016-10-10
Other Devices Sharing Product Codes# 
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