0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line

The CO2 Sampling lines are single-patient, disposable medical devices used to sample exhaled gases from patients for monitoring, typically end-tidal CO2 levels. They connect between the patient's breathing circuit and a capnograph monitor and are intended for use in hospitals, sub-acute care, and pre-hospital settings for patients requiring expired gas monitoring.

The devices consist of flexible extruded PVC tubing with polypropylene and ABS connectors in multiple configurations (models 0184, 0184T, 0139, 0182) with internal diameters of 1.0 or 1.5 mm and lengths of 3 to 3.25 meters. Some models include in-line filters while others do not. All models use standard Luer slip-fit or Luer-lock connections compatible with capnograph monitors and operate as exhaust-only conduits with no reverse gas flow to the patient.

ISO 80369-7 (Luer fitting compatibility), ISO 80601-2-55 (flow and leaks testing), ISO 10993 biocompatibility testing (cytotoxicity, irritation, sensitization for skin contact limited to less than 24 hours), plus mechanical testing including age testing, tensile strength of connections, and back-pressure resistance.

The subject devices are substantially equivalent because they have identical indications for use (expired gas sampling), equivalent environments of use, and comparable patient populations to the predicate K181981. Design, construction, materials, and operational principle are equivalent—both are disposable sampling lines with PVC tubing and standard connectors. Performance testing demonstrates equivalent mechanical properties including flow resistance, connection strength, and Luer fitting compatibility. The only design variations (filter presence, slightly different tube diameters of 1.0 or 1.5 mm versus predicate's 1.10 mm) do not introduce new safety risks compared to the predicate or reference device.