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510(k) Data Aggregation

    K Number
    K011925
    Device Name
    HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO
    Manufacturer
    SIMS PORTEX, INC.
    Date Cleared
    2001-07-12

    (22 days)

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

    SIMS PORTEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    SIMS PORTEX, INC.
    Date Cleared
    2001-02-05

    (200 days)

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

    SIMS PORTEX, INC.

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

    (121 days)

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

    SIMS PORTEX, INC.

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

    (85 days)

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

    SIMS PORTEX, INC.

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

    (185 days)

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

    SIMS PORTEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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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    K Number
    K994275
    Device Name
    SIMS PORTEX ANESTHESIA CATHETER
    Manufacturer
    SIMS PORTEX, INC.
    Date Cleared
    2000-02-22

    (64 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMS PORTEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SIMS Portex Anesthesia Catheter is indicated for the infusion of local anesthetics or narcotics into the intraoperative site for post operative pain management and for regional anesthesia, outside of the epidural space. Routes of administration may include intraoperative or percutaneous. The catheter is not intended for intravenous or intramuscular use.
    Device Description
    The SIMS Portex Anesthesia Catheter is made of flexible, nylon tubing. The catheter may be closed-ended with lateral eyes or an open-ended catheter with finished tip. The tip 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 catheter is available as 21g (O.D. .033"/I.D. .019"). The catheters have a nominal length of 38 inches. The catheters may include a stylete. The catheters are provided with a catheter connector (K965017) to provide a means of administration of anesthetics, analgesics, and/or narcotics. The catheter may be used in conjunction with an infusion pump. The catheter may be used, outside of the epidural space, for up to 30 days. An insertion device may be provided to aid the placement of the catheter into the introducer needle. They are provided sterile in individual packages or as a component of a regional anesthesia procedure tray (K965017).
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    K Number
    K991861
    Device Name
    1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE
    Manufacturer
    SIMS PORTEX, INC.
    Date Cleared
    2000-01-18

    (231 days)

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

    SIMS PORTEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Infant Manual Resuscitator: The 1st Response Infant Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to infant patients suffering from respiratory distress. It is intended for use on patients with a body mass of < 10 kg (22 lbs). Pediatric Manual Resuscitator: The 1* Response Pediatric Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to pediatric patients suffering from respiratory distress. It is intended for use on patients with a body mass of > 10 kg (22 lbs) and <25 kg (55 lbs).
    Device Description
    The 1st Response infant and pediatric manual resuscitators are disposable, single use emergency manual ventilators. 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 reservoir or 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 15mm ID x 22 mm OD patient connector, exhalation port, manometer port, and a pressure limiting valve (PLV). The device is 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
    K992471
    Device Name
    SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18
    Manufacturer
    SIMS PORTEX, INC.
    Date Cleared
    1999-10-22

    (88 days)

    Product Code
    BSO
    Regulation Number
    868.5120
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMS PORTEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SIMS Portex Epidural Catheter is indicated for the injection of local anesthetics into the epidural space.
    Device Description
    The SIMS Portex Epidural Catheter is made of flexible, nylon tubing. The catheter may be closed-ended with lateral eyes or an open-ended catheter with finished tip. The tip 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 catheter is available in 20g (O.D. .042"/I.D. .023") or 21g (O.D. .033"/I.D. . 019") sizes. The catheters have a nominal length of 38 inches. The catheters may include a stylete. The catheters are provided with a catheter connector (K965017) to provide a means of administration of anesthetics and/or analgesics. They are provided sterile in individual packages or as a component of a continuous epidural procedure tray (K965017).
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    K Number
    K992057
    Device Name
    IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006
    Manufacturer
    SIMS PORTEX, INC.
    Date Cleared
    1999-09-13

    (87 days)

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

    SIMS PORTEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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. 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 reservoir or 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. A manometer port is optional. The device is provided with or without a facemask. Special configurations are available which include a disposable manometer, PEEP valve with adapter, or exhalation filter.
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    K Number
    K983858
    Device Name
    SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES
    Manufacturer
    SIMS PORTEX, INC.
    Date Cleared
    1999-01-29

    (88 days)

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

    SIMS PORTEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Spinal needles are indicated for the injection of local anesthetics into a patient to provide regional anesthesia.
    Device Description
    A spinal needle is an instrument used for the injection of local anesthetics into a patient to provide regional anesthesia. The needle consists of a luer hub, a stainless steel cannula, and a stainless steel stylete. The needles are provided as sterile, single use, disposable devices. They may be packaged individually or included in our regional anesthesia trays. The spinal needles are provided in three styles; Lancet Point (Quincke), Pencil Point (Whitacre), and European Style (Sprotte). The introducer needle is a simple hypodermic needle, either 18g or 20g, to make the initial puncture through the skin to aid in the placement of the spinal needle.
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