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510(k) Data Aggregation

    K Number
    K040014
    Device Name
    PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY
    Manufacturer
    PORTEX LTD.
    Date Cleared
    2004-02-13

    (51 days)

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

    PORTEX LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To create a percutaneous dilational tracheostomy using guidewire, single stage dilator and components of this product which allows for tracheal access for airway management.
    Device Description
    The new kit is designed to permit percutaneous creation of a tracheostomy stoma and subsequent insertion of a size 7, 8 or 9mm tracheostomy tube. It employs the well understood and established procedure for dilating a stoma and introducing the tracheostomy tube using the Seldinger over a guide wire system. The kit contains all of the standard components to which the user are accustomed: scalpel, needle and cannula, syringe, guidewire, guiding catheter, Gauze pads, short pre-dilator, dilator system, and tracheostomy tube introducers. The kit differs from the above two kits in that it employs a single tapered dilator to replace the multiple serial dilators. The packaging is the same as that used in k022212. It is designed with an outer blister, which contains an inner tray. The tray layout is designed to present the user with the components in the order of use. Each pack is EO sterilised and individually packed in a carton together with the directions for use.
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    K Number
    K032112
    Device Name
    P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)
    Manufacturer
    PORTEX LTD.
    Date Cleared
    2004-01-26

    (201 days)

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

    PORTEX LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portex Reinforced Tracheal Tubes (cuffed and uncuffed) are designed for oral or nasal intubation for airway management during anaesthesia. The product may be used where the patient's neck is likely to be moved or flexed or the patient is in the prone position so that a non-reinforced tracheal tube might become kinked.
    Device Description
    Single use. A Tracheal tube with additional metal wire spiral reinforcement to provide kink-resistance. This type of product is typically used during operations where a high degree of flexibility is required from the tube, for instance prone position, head and neck surgery, oral surgery. The plastic material and the spring allow the tube to be easily bent in all directions. The steel reinforcement maintains the patency of the lumen. The Portex Ltd PVC, Single-use Reinforced tracheal tube is available in cuffed and uncuffed variants. The cuff is intended to provide a seal against the trachea, ensuring that inspiratory and expiratory gases are directed through the tube and not allowed to escape to the patients upper airway, thus preventing loss of ventilation / anaesthetic and nebulised drugs, and reducing the likelihood of any aspirated stomach contents from entering the lungs. Uncuffed tubes are used mainly for paediatric applications who require less protection from loss of ventilation / anaesthetic and nebulised drugs and or stomach aspiration. The reinforced tracheal tube (Cuffed Murphy eye) is available in sizes 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 and 9.5mm only. The reinforced tracheal tube (Uncuffed) is available in sizes 3.0, 3.5, 4.0, 4.5 and 5.0mm only.
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    K Number
    K033084
    Device Name
    WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER
    Manufacturer
    PORTEX LTD.
    Date Cleared
    2003-12-19

    (81 days)

    Product Code
    MQF
    Regulation Number
    884.6110
    Why did this record match?
    Applicant Name (Manufacturer) :

    PORTEX LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Embryo Replacement Catheters are sterile, single-use devices for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilisation. Trial Transfer Catheters are sterile, single-use devices for determining whether the cervix is passable for a Wallace embryo replacement catheter
    Device Description
    Embryo Replacement Catheters: The Embryo Replacement Catheters (for use in ultrasound-guided transfers) are single use devices for the introduction of embryos into the uterine cavity following in-vitro fertilisation. The devices have overall lengths; 18cm (CE 118A) and 23cm (CE 123A) and consist of a soft, flexible inner cannula, with end opening, and a detachable outer sheath that is attached to the inner catheter by a Luer taper. The inner catheter is of dimensions 1.5mm (OD) x 0.76 mm(ID) with a lumen that is uniform throughout its length, with a series of 1cm graduations at the proximal end. The inner catheter protrudes from the outer sheath by 5cm and the outer sheath has a series of 1cm graduations at the distal end. Trial Transfer Catheters: The Trial Transfer Catheters (for use in ultrasound-guided transfers) are single use devices used to assess the passage through the cervix prior to embryo transfer. The devices have overall lengths; 18cm (CE 418A) and 23cm(CE 423A) and consist of a flexible inner cannula, with blind end, and a detachable outer sheath that is attached to the inner catheter by a Luer taper. The inner catheter is of dimensions 1.5mm (OD) x 0.76 mm(ID) with a series of graduations at the proximal end. The inner catheter protrudes from the outer sheath by 5cm and the outer sheath has a series of 1cm graduations at the distal end.
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    K Number
    K032716
    Device Name
    PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)
    Manufacturer
    PORTEX LTD.
    Date Cleared
    2003-11-28

    (87 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    PORTEX LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thermovent HEPA HME breathing system filter provides bacterial and viral filtration protecting the patient and the breathing circuit or ventilator. It also provides passive heat and humidification to the patient.
    Device Description
    The Thermovent HEPA (High Efficiency Particulate Air) HME (Heat and Moisture Exchange) breathing system filter is a single use bacterial and viral filter with 'HEPA' grade filtration properties. The filter is intended for use with ventilators, anaesthesia breathing circuits, positive breathing systems and passive spontaneous breathing intubated patients. The Thermovent HEPA is a hydrophobic filter, which acts as an effective barrier to both air and liquid borne contaminates. The filter media repels liquid and therefore prevents any liquid moving from the patient side of the device through to the ventilator circuit. To maximise the filtration surface area, the filter media is pleated before assembly into the filter housing. The Thermovent HEPA also acts as a passive, hydrophobic humidifier. The expired gasses from the patient condense on the surface of the media, while releasing latent heat and warming the filter element. On inspiration, the airflow is warmed by the filter element, while the liquefied water is vaporised, thus allowing humidified air to be returned to the patient. The Thermovent HEPA has a Luer port on the machine side of the housing to allow monitoring of the patients gasses, after filtration. The filter housing also features a peg where the user can park the gas sampling port is in use. The devices are packed individually in flexible thermoformed pouch type unit packs.
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    K Number
    K030570
    Device Name
    BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
    Manufacturer
    PORTEX LTD.
    Date Cleared
    2003-09-17

    (205 days)

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

    PORTEX LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portex Blue Line Ultra Suctionaid Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients. Suctionaid allows aspiration of mucous and subglottic secretions that collect and build up between the tracheostomy tube cuff and the glottis.
    Device Description
    The Blue Line Ultra Suctionaid (BLUS) tracheostomy tube provides an airway to the patients lungs when the upper airway / larynx / pharynx or oral & nasal routes are occluded or compromised due to traumatic injury, illness, or during surgery, and is elective for long term ventilated patients. The tube can be used for ventilated, or spontaneously breathing patients. The BLUS is available in sizes 6.0, 7.0, 7.5, 8.0, 8.5 and 9.0mm only. BLUS is cuffed. The cuff provides a seal against the trachea, ensuring that inspiratory and expiratory gasses are routed through the tube and not allowed to escape to the patients upper airway, thus preventing loss of ventilation / anaesthetic and nebulised drugs, and reducing the likelihood of any aspirated stomach contents from entering the lungs. BLUS has a clear suction line terminating with a suction orifice above the cuff which allows any pooled secretions to be aspirated. The suction line terminates with a connector for suction devices and a Luer port to connect to either a syringe or a vacuum control valve which is included in the pack. The outer tube can be used with or without an inner cannula lines the bore of the outer tube, and can be removed, cleaned and replaced to ensure that the bore of the tube is kept patent. The BLUS is supplied pre-loaded onto an obturator. The obturator reduces the risk of the distal end of the product from damaging the trachea upon insertion. The obturator has an internal pathway for a guide wire, so that a guide wire can be used to help position the stoma site for tube change insertion. The BLUS tracheostomy tube is packed in several kit variants to suit clinician preferences. Each kit contains a tracheostomy tube holder, an inner cannula, Tracheostomy tube disconnection wedge, cleaning brush and a patient notes label. The change kit includes a tube change J tip guide wire. This wire is used to help place a second tracheostomy tube in a pre-existing stoma when the first tube needs to be changed. Each kit is individually packed in a blister and shelf carton (tracheostomy tube holder and cleaning bush packed outside of the blister in a polyethylene bag), and the products are sterile by ETO. Replacement Blue Line Ultra inner cannula are available in packs of 20 or 50. The cannula are individually packed in a blister to maintain sterility, and contained within a shelf carton. The inner cannula lines the bore of the outer tube, and can be removed, cleaned and replaced to ensure that the bore of the tube is kept patent.
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    K Number
    K030381
    Device Name
    PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA
    Manufacturer
    PORTEX LTD.
    Date Cleared
    2003-08-27

    (203 days)

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

    PORTEX LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    'Portex Blue Line Ultra Tracheostomy Tube is indicated for airway maintenance of Tracheostomised patients'
    Device Description
    The Blue Line Ultra (BLU) tracheostomy tube provides an airway to the patients lungs when the upper airway / larynx / pharynx or oral & nasal routes are occluded or compromised due to traumatic injury, illness, or during surgery, and is elective for long term ventilated patients. The tube can be used for ventilated, or spontaneously breathing patients. The BLU is available in sizes 6.0, 7.0, 7.5, 8.0, 8.5 and 9.0mm only. BLU is available in cuffed and uncuffed variants. The cuff provides a seal against the trachea, ensuring that inspiratory and expiatory gasses are routed through the tube and not allowed to escape to the patients upper airway, thus preventing loss of ventilation / anaesthetic and nebulised drugs, and reducing the likelihood of any aspirated stomach contents from entering the lungs. Uncuffed tubes are used when patients require less protection from loss of ventilation / anaesthetic and nebulised drugs and or stomach aspiration. The outer tube can be used with or without an inner cannula lines the bore of the outer tube, and can be removed, cleaned and replaced to ensure that the bore of the tube is kept patent. The BLU is supplied pre-loaded onto an obturator. The obturator reduces the risk of the distal end of the product from damaging the trachea upon insertion. The obturator has an internal pathway for a guide wire, so that a guide wire can be used to help position the tube through the stoma site for tube change insertion. The BLU tracheostomy tube is packed in several kit variants to suit clinician preferences. Each kit contains a tracheostomy tube holder, an inner cannula cleaning brush, disconnection wedge and a patient notes label. The change kit includes a tube change i tip guide wire. This wire is used to help place a second tracheostomy tube in a pre-existing stoma when the first tube needs to be changed. Each kit is individually packed in a blister and shelf carton (tracheostomy tube holder and cleaning bush packed outside of the blister in a polyethylene bag), and the products are sterile by ETO. Replacement Blue Line Ultra inner cannula are available in packs of 20 or 50. The cannula are individually packed in a blister to maintain sterility, and contained within a shelf carton. The inner cannula lines the bore of the outer tube, and can be removed, cleaned and replaced to ensure that the bore of the tube is kept patent.
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    K Number
    K031622
    Device Name
    WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS
    Manufacturer
    PORTEX LTD.
    Date Cleared
    2003-06-26

    (34 days)

    Product Code
    MQE
    Regulation Number
    884.6100
    Why did this record match?
    Applicant Name (Manufacturer) :

    PORTEX LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wallace Dual Lumen Oocyte Retrieval Sets are sterile single-use devices for ultrasonic-guided transvaginal collection of oocytes from the ovarian follides.
    Device Description
    The Wallace Dual Lumen Oocyte Retrieval Sets are sterile, single-use devices for ultrasound ~ guided transvaginal collection of Oocytes from ovarian follicles. The set consists of a dual-lumen stainless needle attached to polyurethane tubing. The needle is 33cm in length and available in 16 gauge or 17 gauge sizes, each having 1cm of echomarking at the distal tip for ultrasound reflection and a plastic hub at the proximal end for ease of guidance by hand. Retrieval tubing is attached to the proximal end of the hub and is available in two lengths, protruding a total distance of either 60cm, 75cm or 95cm until it passes through a silicone bung. The Retrieval tubing is sleeved at the needle connection with a silicone sleeve (Blue 16g). Flushing tubing is attached to the top of the hub and extends to either 60cm, 75cm before it terminates in a clear female luer connector. A pump adapter component is included in each pouch pack to allow connection of the pink female Luer connector to vacuum tubing with an internal diameter of between 4 and 10.5mm.
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    K Number
    K012277
    Device Name
    PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE
    Manufacturer
    SIMS PORTEX LTD.
    Date Cleared
    2002-02-11

    (207 days)

    Product Code
    HHW
    Regulation Number
    884.3575
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMS PORTEX LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Portex Ring Pessaries provide vaginal support to prevent the uterus from descending. Designed to ease uterine prolapse. Ring Pessaries are also used to correct other uterine displacements and to alleviate stress incontinence by pressure through the anterior vaginal wall onto the urethra.
    Device Description
    A ring pessary made from PVC or Polythene, available in various sizes, designed to ease uterine prolapse, and provide vaginal support to prevent the uterus from descending.
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    K Number
    K012068
    Device Name
    WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S
    Manufacturer
    SIMS PORTEX LTD.
    Date Cleared
    2001-08-03

    (32 days)

    Product Code
    MQE
    Regulation Number
    884.6100
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMS PORTEX LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wallace Oocyte Retrieval Set is intended for ultrasound-guided, transvaginal recovery and collection of oocytes from ovarian follicles. The Wallace Oocyte Retrieval Sets are sterile, single-use intended for ultrasound-guided, transvaginal collection of oocytes for ovarian follicles.
    Device Description
    Wallace Oocyte Retrieval Set is a single-use device provided sterile for ultrasound-guided, transvaginal recovery and collection of oocytes from ovarian follicles. The set consists of a single-lumen, stainless steel needle attached to polyurethane (Tecoflex) tubing 750mm long, using a 25mm long medical grade silicone sleeve. The needle is 33cm in length and available in 16 gauge or 17 gauge, each having echomarking at the distal tip for ultrasound reflection and a plastic hub at the proximal end for ease of guidance by hand. Tubing is attached to the hub of the needle and protrudes a total distance of 700mm until it passes through a silicone bung and terminates in an ABS female luer connector. FEP tubing for suction also protrudes through the bung, and at the other end terminates in a polypropylene luer lock connector.
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    K Number
    K001555
    Device Name
    SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26
    Manufacturer
    SIMS PORTEX LTD.
    Date Cleared
    2000-08-02

    (76 days)

    Product Code
    HHK
    Regulation Number
    884.1175
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMS PORTEX LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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