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510(k) Data Aggregation

    K Number
    K251216
    Device Name
    0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line
    Manufacturer
    Barbaras Development Inc.
    Date Cleared
    2025-06-04

    (47 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Barbaras Development Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CO2 Sampling lines are the single patient, disposable device intended for monitoring expired gases from the patient. Environment of use – hospital, sub-acute, and pre-hospital settings. Patient population – Patients requiring expired gas monitoring.
    Device Description
    Barbaras Development Inc. CO2 Sampling lines are the accessories in breathing system and intended for sampling of exhaled gases for monitoring, typically end-tidal CO2. The Barbaras Development Inc. CO2 sampling lines are 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. the gas sampling is exhaust only and there is no gas flow back to patient. The Barbaras Development Inc. CO2 Sampling Lines are a disposable, single patient use that allow to sample of patients exhaled gases. It consists of flexible extruded plastic tubes with and standard connectors on each end. We will present several different configurations like have the filter or without filter in the middle which have been tested and compared to predicates. The Barbaras Development Inc. CO2 Sampling Lines are offered in the following models: 0184 CO2 Sampling line, 0184T CO2 Sampling line, 0139 CO2 Sampling line, 0182 CO2 Sampling line. Gas sampling devices are not specific to a particular exhaled gas monitor. Almost all gas sampling line are connected to the monitor via a standard luer fitting, whether it is a female or male fitting.
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