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510(k) Data Aggregation

    K Number
    K111424
    Device Name
    VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH
    Date Cleared
    2011-07-29

    (67 days)

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

    MEDPRO SAFETY PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VACUETTE® PREMIUM Safety Needle System Tube-Touch is used in routine venipuncture procedures. The Needle System is designed with an integrated, multiple sample needle and safety shield. The safety shield is automatically activated and released upon insertion of the first blood collection tube and covers the needle immediately following blood collection from patient. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.
    Device Description
    The VACUETTE® PREMIUM Safety Needle System Tube-Touch is a single-use, sterile needle system, non-toxic, designed with an integrated, multiple use drawing needle and safety shield to provide protection against needlestick injury during venipuncture. This device has no components made of dry natural rubber.
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    K Number
    K102010
    Device Name
    VACUETTE PREMIUM SAFETY BLOOD COLLECTION SET
    Date Cleared
    2010-11-19

    (126 days)

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

    MEDPRO SAFETY PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VACUETTE® PREMIUM Safety Blood Collection Set is used in routine venipuncture procedures. It is used for blood collection. The safety shield is activated automatically to cover the needle immediately following blood collection thus preventing accidental needlestick injury.
    Device Description
    The Vacuette Premium Safety Blood Collection Set is a single use, individually wrapped, sterile winged blood collection needle with an integrated needle and safety shield bonded to a flexible tubing with a female luer adapter allowing the set to be used with a luer system (e.g. Holdex®). It is available with optional Luer Adapter and / or Luer Adapter + Holder. The device is free of PVC, DEHP, Latex.
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    K Number
    K072602
    Device Name
    VACUETTE PREMIUM SAFETY NEEDLE SYSTEM
    Date Cleared
    2008-06-18

    (278 days)

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

    MEDPRO SAFETY PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VACUETTE® Premium Safety Needle System is used in routine venipuncture procedures. The holder is designed with an integrated, multiple sample needle and safety shield. Upon insertion of the first blood collection tube, the safety shield is automatically released. The safety shield covers the needle immediately following blood collection from the patient. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.
    Device Description
    The VACUETTE® PREMIUM Safety Needle System is a single use, sterile holder designed with an integrated, multiple sample needle and safety shield to provide protection against needlestick injury during venipuncture.
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    Ask a specific question about this device

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