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510(k) Data Aggregation
K Number
K181981Device Name
CO2 Sampling Line
Manufacturer
Tylenol Medical Instruments Co., Ltd
Date Cleared
2019-02-06
(196 days)
Product Code
CCK, REG
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
Tylenol Medical Instruments Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CO2 Sample Lines are intended to be used where exhaled gas is monitored. The intended population: Patients requiring expired gas monitoring, adult to pediatrics. The intended environment of use: Hospital-OR, sub-acute, and pre-hospital settings.
Device Description
Breath gas analysis is commonly performed to provide informatin related to a patient's condition. An example of a gas analysis often performed is capnography using an analyzer called a capnograph. Capnography is the monitoring of the time dependent respirary carbon dioxide(CO2) concentration, which may be used to directly monitor the inhaled and exhaled concentration of CO2, and indirectly monitor the CO2 concentration in a patient's blood. CO2 monitoring of patients respired gases can be used to display of information about CO2 production, pulmonary(lung) perfusion, alveolar ventilation (alveoli are hollow cavities in the lungs in which gas exchange is being performed) and respiratory patterns related to a patient's condition during anesthesia. In breath analysis systems, for example capnograraphy, breath gas can be sampled either by a mainstream or a sidestream analyzer. CO2 Sampling Lines are availabe for CQ2 sampling when mainstream capnography is used, so as to perform a mainstream capnographic measurement of the level of CO2. The CO2 Sampling Line is a sterile, disposable, singlie patient use cannula that allows sampling of patients exhaled gases. It consists of flexible extruded plastic tubes with standard connectors on each end. The cannula is a straight and flexible tube which permits the passage of a fluid such as carbon dioxide through an orifice (a buccal or nasal cavity of a patient). In addition, the CO2 sampling line is adapted used to connect between the patient's end of the breathing system and the distant analyzer, such as the capnograph monitor, along this tube, the patient's breath is continuously sampled.
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