Home GUDID 10840619030114 ICU Medical
Primary DI 10840619030114
Brand ICU Medical
Company ICU MEDICAL, INC.
Model 50456-01
Catalog number 50456-01
Device description TriOx™ ScvO2 Central Venous Oximetry Catheter, Heparin Coated, Expanded Kit
Published 2021-08-29
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 DQE Catheter, oximeter, fiber-optic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQE Catheter, Oximeter, Fiber-Optic Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10840619030114 Package GS1 5 In Commercial Distribution 00840619030117 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 10840619030114 10840619030114 00840619030117 00840619030117 840619030117 0840619030117
GMDN Terms# Term, Definition table Term Definition Pulmonary artery balloon catheter, oximetric A flexible tube with an inflatable balloon at its distal tip designed for measuring pulmonary arterial pressures and mixed venous oxygen saturation (SvO2) levels when connected to an appropriate oximetric patient monitor; it may also measure pulmonary artery wedge pressure. It uses a fibreoptic bundle and light-emitting diodes (LEDs) which using light emitted at two or three different wavelengths (e.g., red or near infrared) from the catheter and reflected back from the red blood cells provide the measurements. It is used in emergencies, for monitoring critically ill patients (e.g., acute respiratory failure, severe head injury) and during surgical procedures. This is a single-use device.
Regulatory Flags# DUNS number 118380146 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true 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 50690103218621 SWAN-GANZ TRUE SIZE Edwards Lifesciences LLC DQE 2026-03-16 00690103217711 Acumen AFM™ cable - HemoSphere Alta™ monitor Edwards Lifesciences LLC DQE 2025-07-11 00690103217728 HemoSphere Edwards Lifesciences LLC DQE 2025-07-11 50690103219611 ForeSight IQ Edwards Lifesciences LLC DQE 2025-07-11 10889483591420 Vital Signs™ AirLife Finland Oy DQE 2025-04-02 10889483591437 Vital Signs™ AirLife Finland Oy DQE 2025-04-02 10840619046610 ICU Medical ICU MEDICAL, INC. DQE 2025-03-25 00690103217957 HemoSphere Alta Edwards Lifesciences LLC DQE 2025-03-13 00690103217964 HemoSphere Alta Edwards Lifesciences LLC DQE 2025-03-13 00690103217971 HemoSphere Alta Edwards Lifesciences LLC DQE 2025-03-13 00690103219289 SWAN GANZ Edwards Lifesciences LLC DQE 2024-08-30 50690103219376 SWAN GANZ Edwards Lifesciences LLC DQE 2024-08-30 50690103219383 SWAN-GANZ Edwards Lifesciences LLC DQE 2024-08-05 10840619030091 ICU Medical ICU MEDICAL, INC. DQE 2022-10-04 10840619030084 ICU Medical ICU MEDICAL, INC. DQE 2021-08-29 10840619041516 ICU Medical ICU MEDICAL, INC. DQE 2021-08-29 10840619041578 ICU Medical ICU MEDICAL, INC. DQE 2021-08-29 10840619041875 ICU Medical ICU MEDICAL, INC. DQE 2021-08-29 10840619041967 ICU Medical ICU MEDICAL, INC. DQE 2021-08-29 10840619043565 ICU Medical ICU MEDICAL, INC. DQE 2021-08-29 10840619043572 ICU Medical ICU MEDICAL, INC. DQE 2021-08-29 10840619043596 ICU Medical ICU MEDICAL, INC. DQE 2021-08-29 10840619043619 ICU Medical ICU MEDICAL, INC. DQE 2021-08-29 10840619043657 ICU Medical ICU MEDICAL, INC. DQE 2021-08-29 10840619043671 ICU Medical ICU MEDICAL, INC. DQE 2021-08-29 10840619043688 ICU Medical ICU MEDICAL, INC. DQE 2021-08-29 10840619043695 ICU Medical ICU MEDICAL, INC. DQE 2021-08-29 10840619043701 ICU Medical ICU MEDICAL, INC. DQE 2021-08-29 10840619043732 ICU Medical ICU MEDICAL, INC. DQE 2021-08-29 10840619043756 ICU Medical ICU MEDICAL, INC. DQE 2021-08-29