Home GUDID 05700693918808
TCM 4 series ETX base unit
Primary DI 05700693918808
Brand TCM 4 series ETX base unit
Company Radiometer Medical ApS
Model 391-880
Catalog number 391-880
Device description TCM 4 series ETX base unit
Published 2025-04-23
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name DPZ Oximeter, ear DQA Oximeter KLK Monitor, oxygen, cutaneous, for infant not under gas anesthesia LKD MONITOR, CARBON-DIOXIDE, CUTANEOUS 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 DPZ Oximeter, Ear Cardiovascular 2 DQA Oximeter Cardiovascular 2 KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia Anesthesiology 2 LKD Monitor, Carbon-Dioxide, Cutaneous Anesthesiology 2 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 05700693918808 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05700693918808 05700693918808 5700693918808
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 Humidity 0 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -10 Degrees Celsius 60 Degrees Celsius
Regulatory Flags# DUNS number 308667539 Device count 1 Serial number true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05700693930978 ABL90 FLEX 393-097 393-097 2026-07-09 05700693930985 ABL90 FLEX PLUS 393-098 393-098 2026-07-09 05700699446572 SP90 944-657 944-657 2026-07-09 05700699447579 SP90 944-757 944-757 2026-07-09 05700699461056 SC90 946-105 946-105 2026-07-09 05700699461087 SC90 946-108 946-108 2026-07-09 05700699461094 SC90 946-109 946-109 2026-07-09 05700699461100 SC90 946-110 946-110 2026-07-09 05700699461131 SC90 946-113 946-113 2026-07-09 05700699461605 SC90 946-160 946-160 2026-07-09 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
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