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510(k) Data Aggregation

    K Number
    K033080
    Device Name
    PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER
    Manufacturer
    Date Cleared
    2004-03-10

    (163 days)

    Product Code
    Regulation Number
    868.5140
    Why did this record match?
    Applicant Name (Manufacturer) :

    PORTEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catheter is designed for use primarily in pediatic applications (children under 12 years, infants and neonates) for continuous or intermittent regional anesthesia, e.g. epidural, caudal and peripheral blocks. The duration of use should not exceed 72 hours.
    Device Description
    The Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catherer is made of flexible, nylon tubing. The catheter is open-ended catheter with finished tip. The tipe of the catheter is marked. The catheter has a single mark at 5 cm from the tip with 1 cm increments, up to 20 cm. The 10 cm mark is indicated by two marks, 15 cm by three marks, and 20 cm by four marks. The catherer is available in 24g (O.I). 0.022"/I.D. 0.012") size. The catheters have a nominal length of 36 inches. The catheter includes a stylet. The catheters are provided with a catheter connector to provide a means of administration of anesthetics and/or analgesics. They are provided sterile as a component of a continuous anesthesia conduction catheter mini tray.
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    K Number
    K031057
    Device Name
    PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT
    Manufacturer
    Date Cleared
    2003-07-18

    (106 days)

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

    PORTEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management.
    Device Description
    The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is designed to permit percutaneous insertion of a specifically designed tracheostomy tube. This single cannula Percutaneous Tracheostomy Tube has a radiopaque blue line and is constructed of biocompatible polyvinylchloride material and incorporates a tapered and beveled distal tube tip to facilitate insertion through the percutaneously dilated stoma site. The tracheostomy tube has a neck flange, an integral 15 mm connector, and a cuff which deflates to a low profile on the tube for a smooth transition during insertion. The cuff inflation line has a self sealing Luer valve. The tracheostomy tube is supplied with a disposable inner cannula of the appropriate size. The Percutaneous Tracheostomy Kit comes with the necessary components for percutaneous tracheostomy tube insertion into a stoma created by serial dilation.
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    K Number
    K023793
    Device Name
    1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
    Manufacturer
    Date Cleared
    2003-02-11

    (90 days)

    Product Code
    Regulation Number
    868.5915
    Why did this record match?
    Applicant Name (Manufacturer) :

    PORTEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 1st Response Pediatric Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to patients suffering from respiratory distress. It is intended for use on patients with a body mass of between 10 kg (22 lbs) and 40 kg (88 lbs).
    Device Description
    The 1st Response Pediatric manual resuscitator is a disposable, single use emergency manual ventilator. It is intended for single patient use only. Each device consists of a plastic compressible ventilator bag fitted with control valves at each of the two ends. The inlet valve, opposite the patient end, allows entry of fresh gas into the compressible ventilator bag. The valve blocks escape of fresh gas from the ventilator bag during its compression. Attached to this valve are one of two types of reservoirs; bag reservou or tube reservoirs serve to collect an overflow of oxygen when a supplemental oxygen supply is used. The patient end of the ventilator bag is fitted with a second valve assembly. This valve consists of a 15 mm ID x 22 mm OD patient connector, exhalation port, manometer port and a pressure-limiting valve (PLV). The patient port has a swivel feature to allow the care provider to move the bag around the patient, as needed. Standard configurations of the device are provided with or without a face mask. Special configurations are available which include a disposable manometer, PEEP valve with adapter, or exhalation filter.
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    K Number
    K014115
    Device Name
    1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
    Manufacturer
    Date Cleared
    2002-02-27

    (75 days)

    Product Code
    Regulation Number
    868.5915
    Why did this record match?
    Applicant Name (Manufacturer) :

    PORTEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 1st Response Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to patients suffering from respiratory distress. It is intended for use on patients with a body mass of 25 kg (55 lbs) or more.
    Device Description
    The 1st Response manual resuscitator is a disposable, single use emergency manual ventilator. It is intended for single patient use only. Each device consists of a plastic compressible ventilator bag fitted with control valves at each of the two ends. The inlet valve, opposite the patient end, allows entry of fresh gas into the compressible ventilator bag. The valve blocks escape of fresh gas from the ventilator bag during its compression. Attached to this valve are one of three types of reservoirs; bag reservoir, expandable tube reservoir, or flexible length tube reservoir. These reservoirs serve to collect an overflow of oxygen when a supplemental oxygen supply is used. The patient end of the ventilator bag is fitted with a second valve assembly. This valve consists of a 15 mm ID x 22 mm OD patient connector and exhalation port. The patient port has a swivel feature to allow the care provider to move the bag around the patient, as needed. Standard configurations of the device are provided with or without a breathing mask and with or without a PEEP valve. Special configurations are available which could include; pre-attached components, exhalation filter, varying lengths of oxygen lines, varying sizes of breathing masks, and oropharyngeal airways (Berman and Guedel). The breathing mask consists of a clear flexible cone that features a 22 mm ID port and a clear tacky cushion that contacts the patient's face. The PEEP valve features a 30 mm ID port and a knob to allow the care provider the ability to adjust the amount of PEEP. The PEEP valve can be adjusted from 5-20 cm H2O and uses two springs and a silicone rubber diaphragm to regulate the exhaust pressure.
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    K Number
    K014073
    Device Name
    HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE
    Manufacturer
    Date Cleared
    2002-02-13

    (65 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    PORTEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended for injection of insulin. The needle protection device covers the needle after use to help prevent needle sticks.
    Device Description
    This device is intended for injection of insulin. The needle protection device is an integral pre-attached to the needle. Once the needle/needle protection device is attached to a syringe, the collar hoop hinders removal of the needle protection device from the needle. The Needle-Pro® sheath may be adjusted relative to the desired position. After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. As the needle enters the protective sheath, the needle protection device engages and the needle is contained within the sheath. The device should be immediately disposed into a sharps container. The device is supplied with 26G and 27G needles.
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    K Number
    K011925
    Device Name
    HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO
    Manufacturer
    Date Cleared
    2001-07-12

    (22 days)

    Product Code
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMS PORTEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended for injection or aspiration of fluids utilizing a luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks. The Needle-Pro® device is not designed for use with a luer lock syringe.
    Device Description
    This device is intended for injection or aspiration of fluids utilizing a luer slip syringe. The needle protection device is an integral component of the device as it comes pre-attached to the needle. Once the needle/needle protection device is attached to a syringe, the collar hoop hinders removal of the needle protection device from the needle. The Needle-Pro® sheath may be adjusted relative to the needle bevel by swiveling the orange arm to the desired position. After the procedure is completed, the needle is pressed into the sheath using a onehanded technique. As the needle enters the protective sheath, the needle protection device engages and the needle is contained within the sheath. The device should be immediately be disposed into a sharps container. This device is not designed for use with a luer lock syringe. The device is supplied with 25G, 26G, 27G needles both with and without a syringe.
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    K Number
    K002201
    Device Name
    ELECTROSTATIC HYDROPHOBIC BREATHING FILTER
    Manufacturer
    Date Cleared
    2001-02-05

    (200 days)

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

    SIMS PORTEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K002506
    Device Name
    BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT
    Manufacturer
    Date Cleared
    2000-12-14

    (121 days)

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

    SIMS PORTEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K001318
    Device Name
    CPAP SYSTEM, MODEL 102001
    Manufacturer
    Date Cleared
    2000-07-20

    (85 days)

    Product Code
    Regulation Number
    868.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMS PORTEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K993619
    Device Name
    CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK
    Manufacturer
    Date Cleared
    2000-04-28

    (185 days)

    Product Code
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMS PORTEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Combined Spinal/Epidural Anesthesia System is indicated for the injections of local anesthetics into the spinal and epidural spaces of a patient to provide regional anesthesia. The adminsistration of the spinal anesthesia allows rapid anesthesia onset and the placement of an epidural catheter allows for bolus injections or continuous infusion of local anesthetics or other drugs into the epidural space. The combined spinal epidural needle kit is intended for injection of local anesthetics into the intrathecal space via a spinal needle introduced through the epidural needle, and injection of local anesthetics into the epidural space via the epidural needle, or via an epidural catheter passed through the epidural needle.
    Device Description
    Combined Spinal/Epidural Anesthesia Needles are instruments used for a spinal (subarachnoid) injection of anesthetics, followed by the placement of an epidural catheter to allow modification of the spinal analgesia if necessary, or bolus injections or continuous infusion of local anesthetics or other drugs into the epidural space for subsequent pain relief if required. The spinal needle consists of a luer hub, a stainless steel cannula with a pencil point tip, a stainless steel stylete, and a locking colar. The tuohy epidural needle consists of a luer hub, a stainless steel cannula with a Weiss tip, and a matching flange to accept the spinal needles locking colar. The needles are a matched set. The needles are provided as sterile, single use, disposable devices. They may be packaged as a set or included as a set in our regional anesthesia trays. The sizes are tabulated below: | | Spinal Needle | | |------------------|-------------------------|-------------------------| | | 26g 5 3/16"<br>(132 mm) | 27g 5 3/16"<br>(132 mm) | | Epidural Needle | | | | 17g 3.5" (90 mm) | X | X | | 18g 3.5" (90 mm) | | X | The Tuohy needle and the spinal needle have interlocking collars that enable the spinal needle to be locked into position once the dura has been pierced so that it is secured to the Tuohy needle to prevent acceidental displacement. The numbers on the Tuohy needle hub indicate the distance in millimeters that the spinal needle protrudes from the epidural Tuohy needle.
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