Home GUDID 10190752143838 N/A
Primary DI 10190752143838
Brand N/A
Company AirLife Finland Oy
Model M1045564
Catalog number M1045564
Device description Intratracheal Pressure Sensor
Published 2020-12-15
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name BXO Transducer, Gas Pressure
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BXO Transducer, Gas Pressure Anesthesiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20190752143835 Package GS1 10 In Commercial Distribution 10190752143838 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20190752143835 20190752143835 10190752143838 10190752143838
GMDN Terms# Term, Definition table Term Definition Tracheal pressure catheter A sterile device intended to be used for monitoring the endotracheal pressure of a mechanically ventilated patient. It consists of a Y-piece component that connects an endotracheal tube to a breathing circuit, with a port for an included sensing catheter to be inserted and advanced through the endotracheal tube into the trachea. It is proximally connected to a parent device (e.g., ventilator), which will measure and display the detected endotracheal pressure. It is typically made of plastic material [e.g., polyvinyl chloride (PVC)]. This is a single-use device.
Regulatory Flags# DUNS number 368457563 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810050863025 MEDPAK LIFEPORT, LLC BXO 2024-12-02 00813830024371 Transducer, Guardian II Replacement Kit ACCUTRON, INC. BXO 2023-09-13 00813830027235 FRU, Pressure Transducer, 0-100 PSI ACCUTRON, INC. BXO 2023-09-13 00813830027242 FRU, Pressure Transducer, 0-100 PSI, NPT ACCUTRON, INC. BXO 2023-09-13 00810050862417 MedPak LIFEPORT, LLC BXO 2023-05-24 00810050862387 MedPak LIFEPORT, LLC BXO 2023-03-27 00810050862042 MedPak LIFEPORT, LLC BXO 2022-06-28 00810050861878 Patient Loading Utility System (PLUS) LIFEPORT, LLC BXO 2022-02-04 00810050861793 Patient Loading Utility System (PLUS) LIFEPORT, LLC BXO 2022-01-07 00810050861687 MedPak LIFEPORT, LLC BXO 2021-10-28 00810050861533 Patient Loading Utility System (PLUS) LIFEPORT, LLC BXO 2021-07-21 00810050860710 PLUS LIFEPORT, LLC BXO 2021-01-05 00810050860727 PLUS LIFEPORT, LLC BXO 2021-01-05 20190752143835 N/A Vyaire Medical Oy BXO 2020-12-15 00810050860475 PLUS LIFEPORT, LLC BXO 2020-09-18 00810050860192 MedPak LIFEPORT, LLC BXO 2020-07-07 04710810084126 GaleMed GaleMed Xiamen Co., Ltd. BXO 2015-09-19
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