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510(k) Data Aggregation

    K Number
    K212982
    Device Name
    Medispine - Spinal Needle, Glospine - Spinal Needle
    Manufacturer
    Global Medikit Limited
    Date Cleared
    2022-07-29

    (315 days)

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

    Global Medikit Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Spinal Needle (Quincke Bevel and Pencil Point) is intended for injection of local anesthetics into the subarachnoid space to provide spinal anesthesia for pain management. The device is intended to be used in a professional healthcare environment and not tested for MRI safety.
    Device Description
    Spinal Needles are long, flexible needles of small gauge (typically 18G to 27G) which are available with different types of tips: Pencil point and Quincke bevel. The Spinal Needles are available in a series of combination of needle size and length. The smaller size needles of Pencil point tip are provided with introducer needles to provide support for accessing the tough tissues. Spinal needles have a removable stylet that completely occludes the lumen to avoid block. The stylet is withdrawn after the spinal anesthesia needle has penetrated into the subarachnoid space for injecting anesthetic. The needle hub is luer connector (6% luer taper).
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    K Number
    K193158
    Device Name
    ACENT™ Central Venous Catheter
    Manufacturer
    Global Medikit Limited
    Date Cleared
    2020-11-24

    (376 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Global Medikit Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ACENT™ Central Venous Catheter is an intravascular catheter, designed for infusion of fluid to the central venous system and/or for pressure measurements. - for short-term (less than 30 days) infusion therapy or parenteral nutrition - for continuous or intermittent monitoring of the central venous pressure, - for blood sampling.
    Device Description
    ACENT™ catheters are polyurethane, radiopaque single, double, or triple lumen catheters. The catheter is available in sizes that vary from 4 French through 8 French and lengths 8 cm through 20 cm. Each lumen extends from the vicinity of the distal tip to the main (bifurcation or junction) hub, where it branches via the connector into dedicated extension tubes for infusion of fluids. Each of the extension line has a slide clamp and are labeled to provide identification of the lumen size and location. The catheter body has depth markings, measured in cm from the catheter tips. The extension line marked "distal" is used for device placement with a compatible guide wire. The distal tip is soft to minimize patient trauma during insertion. The device is radiopaque to allow verification of location in the patient. Central venous catheters are inserted into a large vein and threaded into the central venous system.
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