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510(k) Data Aggregation

    K Number
    K190274
    Device Name
    Endotracheal Tube
    Manufacturer
    Tianjin Medis Medical Device Co., Ltd.
    Date Cleared
    2019-07-30

    (172 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin Medis Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for airway management by oral intubation and aid in the removal of subglottic secretions.
    Device Description
    The proposed device, Endotracheal Tube is indicated for airway management and aid in the removal of subglottic secretions. The proposed device is available in ETT-X32 and ETT-X22 two types, the difference between these two types is that the ETT-X32 is provided with pressure indicator which is used to monitor intra-cuff pressure. Both two types are available in a series sizes from 6.0mm in an increment of 0.5mm. The proposed device is intended for adult, provided in sterile and single use.
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    K Number
    K182548
    Device Name
    Accucuff Cuff Pressure Indicator
    Manufacturer
    Tianjin Medis Medical Device Co., Ltd.
    Date Cleared
    2019-01-25

    (130 days)

    Product Code
    BSK
    Regulation Number
    868.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin Medis Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Accucuff Cuff Pressure Indicator is intended to monitor intra-cuff pressures of endotracheal, supraglottic airways or tracheostomy tubes. The device is indicated for the patients from pediatric to adult who have an artificial airway and for which the user would like to monitor cuff pressure.
    Device Description
    The Accucuff™ Cuff Pressure Indicator is intended to monitor the cuff pressure of endotracheal, supraglottic airways or tracheostomy tubes. It is designed with different color coded zones to indicate the normal, negative and positive pressure. The black marker on the device will be moved when the cuff pressure is changed. The device is available in 10-20 cmH2O, 20-29 cmH2O and 40-60 cmH2O three different models to accommodate the intended populations from pediatric to adult.
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    K Number
    K160694
    Device Name
    Disposable Endotracheal tube, sterile, AccuCuff
    Manufacturer
    TIANJIN MEDIS MEDICAL DEVICE CO., LTD.
    Date Cleared
    2017-04-07

    (389 days)

    Product Code
    BTR, BSK
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    TIANJIN MEDIS MEDICAL DEVICE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Disposable Endotracheal Tube device is intended for oral or nasal intubation and for airway management. The Accu-Cuff device is intended to inflate cuffs and to monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes.
    Device Description
    The tracheal tube is disposable and supplied as sterile. It is available in a number of sizes/variants. The tracheal tube is primarily made of polyvinyl chloride. The device is used for airway management by connecting to oxygen delivery equipment via a connector. Reinforced ETTs may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. All variants have a radio-opaque line embedded into the tube which enables identification the device when the patient is X-rayed. All variants have a hole at the tip called a Murphy's eye and a standard connector. Cuffed variants are composed of an inflatable cuff, a lumen and pilot balloon with a one-way valve or pressure indicator. The cuff is specified with high volume and standard volume which is intended to be inflated in the trachea in order to seal the device to prevent loss of gas bypassing the tube and the inhalation of vomit. The patient end, the cuff and the tubular body of these tracheal tubes have short-term contact (< 30 days) with mucous membrane of upper airway. Separately, Accu-cuff™ is used for pre-use check and monitoring the cuff pressure in intubation, treatment and extubation process. The user can Judge the change of intra-cuff pressure by observing the change of black line's location. When the black line point to the zone between the Minimum level of green zone and white line, it means the intra-cuff is too low and need to inflate to cuff. When the black line point to the zone between the Maximum level of green zone and red line, it means the intra-cuff is over-pressurizing and need to deflate.
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