(198 days)
1644 & 1644-T: For use at the equipment connection. Designed to reduce bacterial transmission to and from patient, equipment and environment. CAUTIONS: When used in the exhalation limb in conjunction with a water bath humidifier, a water trap should be placed between the filter and the patient; 1831 & 1831-T: For use at the patient connection. Designed to reduce bacterial/viral transmission and to reduce the loss of patient heat and humidity. CAUTIONS: This product is not suitable for patients with thick or copious secretions: Do not use this product in conjunction with other humidification sources. 1644, 1644-T, 1831, 1831-T: ISO connections: When assembling any connections use a push and twist action to ensure a secure fit. Single patient use. Non conductive. Non sterile. Do not autoclave. CAUTIONS: Never position any filter on the inspiratory limb downstream of a water bath humidifier; Do not use this product between the patient and a source of nebulized drugs; When nebulized drugs are administered, resistance should be monitored and the product should be exchanged following standard hospital procedure; All ports should remain capped when not in use; Replace every 24 hours or more frequently if visible deterioration is observed, following standard hospital procedure; Federal law restricts this device to sale by or on the order of a physician.
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This document is a 510(k) clearance letter from the FDA for "Breathing Filters Models 1644, 1644T, 1831 and 1831T." It does not provide details about acceptance criteria or a study proving device performance. This letter merely states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval and classification, not on the technical performance data or specific studies conducted.
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).