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510(k) Data Aggregation

    K Number
    K192511
    Device Name
    Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm
    Manufacturer
    Venner Medical (Singapore) PTE Ltd
    Date Cleared
    2020-07-22

    (314 days)

    Product Code
    BTO
    Regulation Number
    868.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Venner Medical (Singapore) PTE Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Venner PneuX™ TT (Tracheostomy Tube) is intended to be inserted into the patient's tracheostomy stoma during extended periods (not more than 30 days) of intensive or critical care to facilitate ventilation and for the evacuation or drainage of secretions from the subglottic space.
    Device Description
    The Venner Pneux TT (Tracheostomy Tube) is a disposable, sterile, single-patient, single-use device. It is a flexible, low volume and low pressure cuffed tracheostomy tube, which is reinforced with a Nitinol wire. The Venner PneuX TT may be used with the Venner PneuX TSM™ to monitor, maintain and regulate cuff pressure. The Venner PneuX TSM was cleared for marketing via 510(k) application K110631. The Venner PneuX TT is available in three sizes (inner diameters: 7.0, 8.0 and 9.0 mm) and is MRI Conditional. Depth markings indicate the distance to the distal tip of the tube and a printed black line provides a means to orient the tube. The device provides access to subglottic space by having three additional lumens running along the airway lumen. The three lumens are integrated into the tube wall ending just above the proximal end of the cuff for ease of suction. Connected to the suction tube and subglottic connector, it allows intermittent suctioning of secretions from the subglottic space, and irrigation. A winged tube holder allows for securement with openings on each end for a head/neck strap to pass through. A fixation block secures the position of the tube to preventunintended movement during use. A standard connector (15 mm) for universal attachment to a ventilator is present, as well as an inflation line to connect the cuff for inflation and deflation. A pilot balloon connects the cuff to provide an indication of the pressure within the cuff and the pilot valve opens to allow free flow of air to the cuff for inflation when a Luer lock syringe is engaged. When the syringe is removed, the valve closes to prevent leakage of air and ensures the cuff is inflated. The obturator fits in the airway tube of the TT and guides its placement. Its tip is designed to aid passage through the surgical opening of a tracheostomy stoma. The obturator also has a hole which allows a guidewire to pass through, if clinically required.
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    K Number
    K192120
    Device Name
    Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm
    Manufacturer
    Venner Medical (Singapore) Pte Ltd
    Date Cleared
    2020-02-14

    (192 days)

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

    Venner Medical (Singapore) Pte Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Venner Pneux ™ ETT (Endotracheal Tube) is intended to be used for patients undergoing tracheal intubation during routine anesthesia or over extended periods (not more than 30 days) and for the evacuation or drainage of secretion from the subglottic space.
    Device Description
    The Venner PneuX ETT (Endotracheal Tube) is a disposable, sterile, single-patient, single-use device. It is a straight, flexible cuffed (low volume, low pressure) Nitinol wire-reinforced tracheal tube with a Murphy Eye. When a patient is intubated with a Venner PneuX ETT and inflated by standard techniques, it can be attached to the Venner PneuX TSM™M via the Venner PneuX™ Extension Tube, to monitor, maintain and regulate cuff pressure. The Venner Pneux TSM, a cuff pressure controller, was cleared for marketing via 510(k) application K110631 and the Venner PneuX Extension Tube is a class I, 510(k) exempt device. The Venner PneuX ETT is available in four sizes (inner diameters: 6.0, 7.0, 8.0 and 9.0 mm) and is MRI compatible. Depth markings indicate the distal tip of the tube and a printed black line provides a means to orient the tube. The device provides access to subglottic space by having three additional lumens running along the airway lumen. The three lumens are integrated into the tube wall ending just above the proximal end of the cuff for ease of suction. Connected to the suction tube and subglottic connector, it allows intermittent suctioning of secretions from the subglottic space, and irrigation. A winged tube holder allows for securement with openings on each end for a head/neck strap to pass through. An integrated bite block with fixation block provides a protective covering and secures the position of the tube to preventunintended movement duringuse. A standard connector (15mm)for universal attachment to a ventilator or anesthesia equipment is present, as well as an inflation line to connect the cuff for inflation and deflation. A pilot balloon connects the cuff to provide an indication of the pressure within the cuff and the pilot valve opens to allow free flow of air to the cuff for inflation when a Luer lock syringe is engaged. When the syringe is removed, the valve closes to prevent leakage of air and ensures the cuff is inflated.
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    K Number
    K191602
    Device Name
    APA Oxy Blade
    Manufacturer
    Venner Medical (Singapore) Pte Ltd
    Date Cleared
    2019-08-02

    (46 days)

    Product Code
    CCW
    Regulation Number
    868.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    Venner Medical (Singapore) Pte Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The APA Oxy Blade™ is a multi-functional, single-use, disposable larynoscope blade intended to assist in direct and indirect laryngoscopy and to facilitate and aid in tracheal intubation in routine and difficult airways in adult patients. The APA Oxy Blade™ incorporates an oxygen tube adaptor and tubing to provide supplemental oxygen to the patient while undergoing endotracheal intubation.
    Device Description
    The APA Oxy Blade is a laryngoscope blade intended to be used with the Venner Medical APA™ Video Laryngoscope. The APA Oxy Blade is a standard MacIntosh laryngoscope blade with the addition of an oxygen tube adaptor/holder and tubing to provide supplemental oxygen to the patient when using the Venner APA Video Laryngoscope. The Venner APA Video Laryngoscope, like other rigid laryngoscopes, provides a clear view of the upper airway (trachea/airway) and aids in the placement of an endotracheal tube for intubation.
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    K Number
    K110631
    Device Name
    VENNER TRACHEAL SEAL MONITOR
    Manufacturer
    VENNER MEDICAL (SINGAPORE) PTE LTD
    Date Cleared
    2011-07-28

    (146 days)

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

    VENNER MEDICAL (SINGAPORE) PTE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Venner™ Tracheal Seal Monitor (TSM) is indicated for use to monitor, maintain and regulate the pressure within the PneuX P.Y.TM Endotracheal or Tracheostomy Tube Cuff in adult patients who have been confined to hospital ICU units where intubation is expected to be more than 24 hours, but less than or equal to 30 days.
    Device Description
    The Venner™ Tracheal Seal Monitor consists of an automatic inflation cuff controller (control unit) that connects to the Venner™ PneuX P.Y.TM Endotracheal or Tracheostomy Tube using a single patient use, sterile extension tube. The Venner™ Tracheal Seal Monitor regulates and maintains cuff pressure in endotracheal and tracheostomy tubes in adult patients in the intensive care unit (ICU) setting. The device is intended to measure, monitor and maintain a stable cuff pressure in endotracheal and tracheostomy tubes. The Venner™ Tracheal Seal Monitor consists of an electronic automatic pressure controller with a pressure sensors and a pump, and provides a user interface with adjustable settings, indicators and alarms.
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    K Number
    K100950
    Device Name
    VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE
    Manufacturer
    VENNER MEDICAL (SINGAPORE) PTE LTD
    Date Cleared
    2010-07-13

    (98 days)

    Product Code
    BTO
    Regulation Number
    868.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    VENNER MEDICAL (SINGAPORE) PTE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Venner PneuxP. Y.TM Tracheostomy Tube (TT) is a tracheostomy tube intended to be inserted into the patient's trachea via a tracheostomy stoma during extended periods (not more than 30 days) of intensive or critical care to facilitate ventiliation and for evacuation or drainage of secretion from the subglottice space.
    Device Description
    Venner Pneux P.Y.TM TracheostomyTube
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    K Number
    K093135
    Device Name
    VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE
    Manufacturer
    VENNER MEDICAL (SINGAPORE) PTE LTD
    Date Cleared
    2010-04-02

    (179 days)

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

    VENNER MEDICAL (SINGAPORE) PTE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Venner PneuxP.Y.TM EndoTracheal Tube (ETT) is an endotracheal tube intended to be used for patients undergoing tracheal tube intubation during extended periods (not more than 30 deays) and for evacuation or drainage of secretion from the subglottice space. It is also compatible with tracheal intubation during routine anesthesia.
    Device Description
    Not Found
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