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510(k) Data Aggregation
K Number
K161250Device Name
OC-FLEX Flexible IntraOral Cannula
Manufacturer
Venture Therapeutics, Inc.
Date Cleared
2017-03-17
(318 days)
Product Code
CCK
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
Venture Therapeutics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OC-FLEX® Flexible IntraOral Cannula is an adjunct to oxygen therapy with its primary function being that of delivering low flow oxygen to a patient while providing a means to sample expired gas. It is intended for use in patients requiring oxygen therapy to improve blood oxygen levels while monitoring expired gas to determine ventilatory rate.
Device Description
The OC-FLEX® Flexible IntraOral Cannula is a disposable, non-sterile, single use device that is intended to provide a means for sampling exhaled gases from a patient (i.e., end-tidal CO2) with the option to simultaneously or independently deliver supplemental gas therapy (i.e., O2).
The device design consists of dual, conjoined PVC tubing united by an end cap providing two separate gas pathways. One portion of the tubing is dedicated to supplying gas from a gas source to the patient as required by the prescribed therapy. The other portion of the tubing is dedicated to the sampling of exhaled gas from the patient to a gas analyzer (i.e., a capnograph) for end-tidal CO2 monitoring. The design of the OC-FLEX® Flexible IntraOral Cannula incorporates a flexible wire located inside a separate, dedicated lumen in the gas supply tubing in conjunction with an end cap comprised of a filter. The flexible wire feature of the cannula is isolated from the delivery gas as well as the exhaled gas in a dedicated lumen within the gas supply tubing. This allows customizable positioning of the cannula for delivery and sampling of gas. This design is engineered to provide the practitioner flexibility and mobility during the procedure. The end cap minimizes occlusion during sampling of exhaled gas and segregates the gas sampling from the supplied gas for therapy to the patient. This design feature allows the delivery of the prescribed gas (i.e., oxygen) to the oral cavity. The end cap design features a 3-micron hydrophobic filter, which prevents the transfer of water vapor or other body fluid from the patient down to the monitoring line and into the gas sampling equipment.
The OC-FLEX® Flexible IntraOral Cannula is a single patient device, designed for use by one patient over a single course of treatment. The device is available with either a male luer connector or female luer connector. The device is supplied in a sealed poly bag in a non-sterile state and is not to be sterilized.
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