DEVICE: TCM4 combi module, TCpO2/O2 combi module (05700699027788)

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Device Identifier (DI) Information

TCM4 combi module, TCpO2/O2 combi module
902-778
902-778
Radiometer Medical ApS
05700699027788
GS1
1
TCM4 combi module, TCpO2/O2 combi module
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN 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.
Transcutaneous blood gas monitor, paediatric A mains electricity (AC-powered) device designed for the continuous, transcutaneous (through the skin) measure of the partial pressure of oxygen (pO2) and the partial pressure of carbon dioxide (pCO2) in a paediatric patient's blood. It includes a special sensor that is typically heated to increase the blood flow and gas diffusion at the point of application on the skin's surface. The gas then diffuses through the membrane of the sensor and is measured by the device; results are digitally displayed and/or printed. This device is especially used to measure and display pO2/pCO2 in infants not under gas anaesthesia.
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FDA Product Code

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Product Code Product Code Name
LKD MONITOR, CARBON-DIOXIDE, CUTANEOUS
DQA Oximeter
KLK Monitor, oxygen, cutaneous, for infant not under gas anesthesia
LPP Monitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 01, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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Yes
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Customer Contact

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+459999999999
radiometer@radiometer.dk
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