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510(k) Data Aggregation

    K Number
    K123699
    Device Name
    FAHL TRACHEOSTOMY TUBES (MULTIPLE)
    Manufacturer
    ANDREAS FAHL MEDIZINTECHNIK-VERTRIEB GMBH
    Date Cleared
    2013-08-12

    (252 days)

    Product Code
    JOH, BTO, BTR
    Regulation Number
    868.5800
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    Matched: '868.5375'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fahl Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.
    Device Description
    The Fahl Tracheostomy Tubes (Duravent, Duracuff, Laryngotec, Duratwix, Silvervent, Spiraflex, and Tracheotec) are available cuffed or uncuffed. They can be obtained sieved or unsieved, with or without speaking valve, cuffed or uncuffed, with or without inner cannulas. The accessories comprise different Humid Moist Exchangers (HME), decannulation plugs, neck holders, and stoma buttons. Fahl offers the tubes in varying sizes and length so that the physician can select a tracheostomy tube, which best fits the individual needs of the patient. All Fahl Tracheostomy Tubes are for adults only and available on prescription.
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    K Number
    K120079
    Device Name
    PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
    Manufacturer
    PRIMED HALBERSTADT MEDIZINTECHNIK GMBH
    Date Cleared
    2012-05-24

    (135 days)

    Product Code
    BTO
    Regulation Number
    868.5800
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    Matched: '868.5375'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Primed Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.
    Device Description
    The Primed Tracheostomy Tubes consists of various types of tracheostomy tubes, e.g., Primedistom Cannulas w/wo cuff, Silver Cannulas, Priflex Cannulas, Silicone Cannulas (Primedi Silk), and Primedi Star Cannulas. The tracheostomy tubes are made of different materials and offer a variety of inner and outer diameters and varying lengths thus making it possible to meet the individual needs of a patient. The Primed Tracheostomy Tubes can be obtained sieved or unsieved, with or without speaking valve, cuffed or uncuffed, with or without one or two inner cannulas. The accessories comprise different speaking valves as well as Humid Moist Exchangers (HME) and different types of filters.
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    K Number
    K072002
    Device Name
    FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55
    Manufacturer
    DRAEGER MEDICAL AG & CO. KG
    Date Cleared
    2008-01-31

    (192 days)

    Product Code
    CAH
    Regulation Number
    868.5260
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    Matched: '868.5375'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CareStar 30 and SafeStar 55 are Breathing System Filters which are designed to reduce possible airborne or liquid-borne cross contamination with micro-organisms and particulate matter via anaesthetic or ventilator breathing systems. The products may either be used on the patient side or on the device side of the ventilator/ anaesthetic device and are used as a hygienic measure alternatively to decontamination of breathing system and/or breathing gas conveying parts of the ventilator. TwinStar 55 is a Breathing System Filter and a Heat and Moisture Exchanger. The combination of a filter and a Heat and Moisture Exchanger offer the benefit of both product features. Heat and Moisture Exchanger are used as a conditioning system for mechanically ventilated patients whose upper airways are bypassed. In almost all cases of mechanical ventilation they are a fully valid alternative to heated humidifiers. The products are the only conditioning opportunity of breathing gases in cases of emergency ventilation or during transport since Heated Humidifiers are almost impossible to use. The products mentioned above are designed for disposable use and should be changed at least every 24 hours.
    Device Description
    The filters CareStar 30 and SafeStar 55 are designed to reduce possible air or liquid borne cross contamination with microorganisms via anesthetic or ventilator breathing systems. The strategic use of an effective breathing filter protects, bi-directionally, both the patient and equipment. The filter CareStar 30 contains an electrostatic filter pad while the filter SafeStar 55 incorporates a mechanical pleated filter pad. Both filters consist of a plastic body which incorporates 22 female / 15 male connectors in accordance with EN ISO 5326 and a luer lock connector which may only be used for gas monitoring. The Filter/HME TwinStar 55 is designed to combine the feature of reducing possible cross contamination with micro-organisms and an ideal heat and moisture return. The Filter/HME TwinStar 55 consist of a plastic body which incorporates an electrostatic filter pad, 22 female / 15 male connectors in accordance with EN ISO 5326 and a gas luer lock connector which may only be used for gas monitoring.
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    K Number
    K964382
    Device Name
    HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)
    Manufacturer
    GIBECK, INC.
    Date Cleared
    1997-04-15

    (162 days)

    Product Code
    CAH
    Regulation Number
    868.5260
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    Matched: '868.5375'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight are heat and moisture exchangers as described in 21 CFR 868.5375 These products are substantially equivalent to the Gibeck Humid-Vent Filter heat and moisture exchanger. The Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight are similar in design, materials and function to the Humid-Vent Filter with reduced size, dead space and lighter weight. The reduced dead space of the Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight allows for a tidal volume range of 150-1000 ml.
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