Home GUDID 05700699025647
O2 module for the TCM4XX Series
Primary DI 05700699025647
Brand O2 module for the TCM4XX Series
Company Radiometer Medical ApS
Model 902-564
Catalog number 902-564
Device description O2 module for the TCM4XX Series
Published 2016-09-01
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name LPP Monitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LPP Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05700699025647 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05700699025647 05700699025647 5700699025647
GMDN Terms# Term, Definition table Term Definition Transcutaneous blood gas monitoring system An assembly of mains electricity (AC-powered) devices designed for the continuous and transcutaneous measurement of a patient's blood gas parameters, typically blood partial pressure of oxygen (pO2), blood partial pressure of carbon dioxide (pCO2), haemoglobin oxygen saturation (SpO2), and/or venous blood oxygenation through the jugular vein (SjvO2); often with pulse rate. It consists primarily of a probe for gas detection (e.g., via transcutaneous gas diffusion, or using light spectroscopy) placed on the patient’s skin, and an oximetry monitor for the measurement, analysis, and display of data; patient adhesives and connecting cables may be included.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Humidity 0 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 60 Degrees Celsius
Regulatory Flags# DUNS number 308667539 Device count 1 Lot or batch true Serial number true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05700699428929 SAFE CLINIT. D957P-70-100X1 942-892 942-892 2022-12-05 05700699428936 SAFE CLINIT. D957P-70-125X1 942-893 942-893 2022-12-05 05700699428981 SAFE CLINITUBES D957P-70-70X1 942-898 942-898 2024-07-01 05700699429698 safeClinitubes D957P-70-45 942-969 942-969 2022-12-05 05700699440174 QUALICHECK 5+, LEVEL 1 944-017 944-017 2022-12-05 05700699440198 QUALICHECK 5+, LEVEL 3 944-019 944-019 2022-12-05 05700699440822 AUTOCHECK 3+, LEVEL 1, S7335 944-082 944-082 2022-12-05 05700699440839 AUTOCHECK 3+, LEVEL 2, S7345 944-083 944-083 2022-12-05 05700699440846 AUTOCHECK 3+, LEVEL 3, S7355 944-084 944-084 2022-12-05 05700699440853 AUTOCHECK 3+, LEVEL 4, S7365 944-085 944-085 2022-12-05 05700699058027 Disposable Waste Container D513 REF 905-802 905-802 905-802 2018-09-21 05700699058713 Membraning kit for tc sensor 84 905-871 905-871 2016-09-01 05700699060266 ABL90 FLEX, Clot catcher 906-026 906-026 2016-09-01 05700699420589 Membrane for E1001 electrode 942-058 942-058 2016-09-01 05700699420633 Membrane for E788 electrode 942-063 942-063 2016-09-01 05700699420640 Membrane for E799 electrode 942-064 942-064 2016-09-01 05700699420664 Membrane for E7077 electrode 942-066 942-066 2016-09-01 05700699439062 S5362 REF 943-906 943-906 943-906 2018-09-21 05700699440211 Calibration Solution 944-021 944-021 2016-09-01 05700699441263 Cleaning Solution with additive S8375 REF 944-126 944-126 944-126 2018-09-21
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