BEUDAMED
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    ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.

    FDA Enforcement
    Class II ·Terminated·Radiometer America Inc·January 29, 2014

    Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.

    FDA Enforcement
    Class II ·Terminated·Radiometer America Inc·October 9, 2013

    TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.

    FDA Enforcement
    Class II ·Terminated·Radiometer America Inc·August 14, 2013

    Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092 The Radiometer ABL90 Series is a portable, automated analyzer for use in the laboratory environment, near patients or point-of-care settings.

    FDA Enforcement
    Class II ·Ongoing·Radiometer Medical ApS·April 30, 2025

    ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) " In vitro testing of samples of expired air for the parameters pO2 and pCO2 " In vitro testing of pleura samples for the pH parameter.

    FDA Enforcement
    Class II ·Ongoing·Radiometer Medical ApS·July 31, 2024

    AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets the user send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·May 9, 2018

    ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·April 29, 2020

    AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles.

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·February 5, 2020

    TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Usage: It is indicated for use on pediatrics and adults.

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·April 29, 2020

    Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and ABL800Basic. The FlexQ module is optional and can be added to all models and configurations.

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·July 15, 2020

    Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available as ABL837. The FlexQ module is optional and can be added to all models and configurations.

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·July 15, 2020

    ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·April 29, 2020

    ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) In vitro testing of samples of expired air for the parameters pO2 and pCO2 In vitro testing of pleura samples for the pH parameter.0693938004 and 393-801/05700693938011 - Product Usage:

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·April 15, 2020

    ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004

    FDA Enforcement
    Class II ·Ongoing·Radiometer Medical ApS·May 6, 2020

    safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·June 10, 2020

    ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·July 8, 2020

    safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·June 10, 2020

    safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·June 10, 2020

    ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·July 8, 2020

    PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler product line for collection of arterial samples for pH, blood gas, oximetry, electrolyte and metabolite analysis. Model Number/Product Description: 956-518 PICO70 w/o needle; 956-519 PICO70 w/o needle; 956-522 PICO70 22G x 25 mm; 956-525 PICO70 22G x 32 mm; 956-529 PICO70 23G x 16 mm; 956-533 PICO70 23G x 25 mm; 956-534 PICO70 23G x 32 mm; 956-547 PICO70 25G x 16 mm;

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·June 2, 2021