Home GUDID 20190752143835 N/A
Primary DI 20190752143835
Brand N/A
Company Vyaire Medical Oy
Model M1045564
Catalog number M1045564
Device description Intratracheal Pressure Sensor
Published 2020-12-15
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
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 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true 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 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 10190752143838 N/A AirLife Finland 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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