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510(k) Data Aggregation

    K Number
    K090809
    Device Name
    MPS ACACIA POWER INJECTABLE INFUSION SET
    Manufacturer
    MPS ACACIA
    Date Cleared
    2009-04-28

    (34 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    MPS ACACIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Power Injectable Infusion Set with Huber Needle is indicated for: - Use with implanted infusion ports for continuous or intermittent infusion therapy. . - Infusion or withdrawal of IV fluids, blood, blood products, or drugs. . - Use with ports that are indicated for power injection of contrast media into the central . venous system. For power injection of contrast media, the maximum recommended infusion rate is 5ml /sec. for 19 gauge and 20 gauge needles, and 2mL/sec. for 22 gauge needles. - Power injection of contrast media up to 325 PSI. . The Power Injectable Infusion Set with male luer lock is indicated for: - Use with central venous catheters for continuous or intermittent infusion therapy. . - Infusion or withdrawal of IV fluids, blood, blood products, or drugs. ● - Use with central venous catheters that are indicated for power injection of contrast media . into the central venous system. - . Power injection of contrast media up to 325 PSI.
    Device Description
    The Power Injectable Infusion Set, consists of a female luer lock, non-DEHP PVC tubing, on/off clamp, and either a male luer lock for connection to female hub central venous catheters or Huber needle for insertion into implanted port catheters. The Power Injectable Infusion Set will be provided as a sterile, single use, non-pyrogenic, disposable device and will be available in a variety of lengths and sizes.
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    K Number
    K080328
    Device Name
    MPS ACACIA ENTERAL FEEDING TUBE
    Manufacturer
    MPS ACACIA
    Date Cleared
    2008-05-14

    (97 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    MPS ACACIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MPS Acacia Enteral Feeding Tube is intended to be placed into the stomach, nasogastrically or orogastrically, for the introduction of fluids and/or oral medication. The Enteral Feeding Tube is disposable and single use only. Not intended for intravascular or intravenous use.
    Device Description
    The MPS Acacia Enteral Feeding Tube is a polyurethane or polyvinyl chloride (PVC) tube of various French sizes and lengths. A rigid female oral connector is attached to the proximal end of the Enteral Feeding Tube and accepts all male oral connectors such as those found on oral syringes.
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    K Number
    K052451
    Device Name
    MPS ACACIA MEDFLO ELASTOMERIC PUMP
    Manufacturer
    MPS ACACIA
    Date Cleared
    2005-12-08

    (92 days)

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

    MPS ACACIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. The MPS Acacia MedFlo Elastomeric Pump is indicated for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy, and pain management. Routes of administration include intravenous, intra-arterial, subcutaneous, intramuscular, and epidural. The keep vein open (KVO) version provides a sufficient flow rate to maintain a patient IV line open (i.e. keep vein open). The MedFlo Elastomeric pump may also include an optional Ysite at the distal end of the administration set to allow piggyback infusions, and an optional bolus mechanism intended for patient controlled infusion. 2. The MPS Acacia MedFlo Elastomeric Pump is also indicated for continuous and/or intermittent delivery of medication, such as local anesthetics or narcotics, to surgical wound sites and/or close proximity to nerves for preoperative, perioperative, and postoperative regional anesthesia and pain management. Routes of administration include intraoperative, perineural, and percutaneous. 3. The MPS Acacia MedFlo Elastomeric Pump is also indicated to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management. 4. The MPS Acacia MedFlo Elastomeric Pump is disposable and single use only.
    Device Description
    The MPS Acacia MedFlo Elastomeric Pump consists of a non-latex elastomeric bladder that is secured onto a plastic mandrel. Secured to the inside of the mandrel is the non-DEHP administration tubing. Secured to the opposite end of the administration tubing is a male luer lock. Standard IV set accessories are integrated in the administration set of the elastomeric pump and may include (dependant on application as determined by the clinician) an air eliminating filter, pinch clamp, flow restrictor (fixed or variable), Y-site, checkvalve, and bolus mechanism. At the inlet port of the mandrel is a one-way checkvalve to allow for the filling of the device while not allowing fluid backup. Encasing the bladder, mandrel and part of the administration tubing is a clear, protective body. The elastomeric pump does not have an alarm function, is non-DEHP and does not contain latex. The MPS Acacia MedFlo Elastomeric Pump will be available in configurations consisting of 50 to 500ml fill volume, and 0.5 to 10ml per hour flow rates. A procedure kit may consist of an introducer, tear-away sheath, multi-port catheter, syringe, sterile tape, wound dressing, and sterile gloves (dependent on application as determined by the clinician), and may be included with each MedFlo Elastomeric Pump or sold separately dependent on the clinician's requirements.
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    K Number
    K052946
    Device Name
    MPS ACACIA NERVE BLOCK NEEDLE
    Manufacturer
    MPS ACACIA
    Date Cleared
    2005-12-08

    (49 days)

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

    MPS ACACIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. The MPS Acacia Nerve Block Needle is intended for the administration of local anesthetic agents to provide regional anesthesia or the administration of anti-inflammatory medication to relieve chronic pain conditions, or to facilitate placement of a catheter. 2. The MPS Acacia Nerve Block Stimulating Needle version is also intended to aid in locating specific peripheral nerves or nerve plexuses for the precise delivery of local anesthetic agents or anti-inflammatory medication for the relief of chronic pain conditions or to provide regional anesthesia, or to facilitate placement of a catheter. 3. Routes of administration may include Peripheral nerve blocks, Sympathetic blocks, Selective nerve blocks, Intra-articular injections (i.e. Facet blocks), Interlaminar and Transforaminal approaches.
    Device Description
    The MPS Acacia Nerve Block Needle consists of a stainless steel cannula with various tip types (Blunt, Housted, Touhy, Crawford, Quincke, Chiba, Sprotte, Freeman) and a molded plastic hub. A stylet is also provided consisting of a stainless steel shaft and a molded plastic hub. The MPS Acacia Nerve Block Stimulating Needle version is electrically conductive at the distal end of the device. The Nerve Block Needle will be provided as a sterile, single use, non-pyrogenic, disposable device and will be available in a variety of lengths and gauges. The Nerve Block Needle may be packaged individually or as part of a kit consisting of a catheter, various syringe sizes, introducer, extension set, gauze sponge, sponge applicator, drape, absorbent towel, hospital wrap, sterile gloves, and other commonly used FDA approved accessories dependent on the application as determined by the clinician.
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    K Number
    K032934
    Device Name
    MPS ACACIA SAFEGUARD HUBER DEVICE
    Manufacturer
    MPS ACACIA
    Date Cleared
    2003-11-13

    (52 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    MPS ACACIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MPS Acacia Safeguard Huber Device is intended: a) for use with implanted infusion ports for continuous or intermittent infusion therapy; and b) for infusion or withdrawal of I.V. fluids, blood, blood products, and drugs. The MPS Acacia Safeguard Huber Device should be changed per CDC guidelines or per hospital protocol.
    Device Description
    The MPS Safeguard Huber Device is a family of sterile and non-pyrogenic devices used for transdermal infusion via subcutaneous access ports. These devices consist of angled non-coring stainless steel needle bonded to infusion tubing ending with a standard female luer lock connector. Each set is provided with a needle tip protector, and luer cap. Various configurations may also include Y-injections sites, needleless injection sites, and clamps associated with standard tubing infusion sets. The MPS Acacia Safeguard Huber Device is designed to allow the clinician to activate a trigger on the device that will deploy a protective sheath to cover the entire needle once the device is removed from the patient. The device is designed to help minimize accidental needlestick injuries.
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    K Number
    K011117
    Device Name
    MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS
    Manufacturer
    MPS ACACIA
    Date Cleared
    2001-07-09

    (88 days)

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

    MPS ACACIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003476
    Device Name
    MPS ACACIA PAIN KIT
    Manufacturer
    MPS ACACIA
    Date Cleared
    2001-01-12

    (64 days)

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

    MPS ACACIA

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

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