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510(k) Data Aggregation

    K Number
    K090502
    Device Name
    NOVA SAFE SCALP VEIN BLOOD COLLECTION SET
    Manufacturer
    U.S. SAFETY SYRINGES CO., INC.
    Date Cleared
    2009-03-10

    (13 days)

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

    U.S. SAFETY SYRINGES CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K090122
    Device Name
    NUOVOGUARD
    Manufacturer
    U.S. SAFETY SYRINGES CO., INC.
    Date Cleared
    2009-02-05

    (15 days)

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

    U.S. SAFETY SYRINGES CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NUOVOguard IV Catheter in sizes 14G to 26G is used to provide access into the peripheral vascular system for the administration of fluids and drugs and for withdrawal of blood. The NUOVOguard provides a passive safety tip clip to protect from the accidental needle stick injury after cannulations
    Device Description
    Not Found
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    K Number
    K083454
    Device Name
    NUOVOCATH
    Manufacturer
    U.S. SAFETY SYRINGES CO., INC.
    Date Cleared
    2008-12-04

    (13 days)

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

    U.S. SAFETY SYRINGES CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NUOVOcath IV Catheter in size 14G to 26 G is used for venous access for the infusion of I.V. fluids, medicines into the circulating system.
    Device Description
    NUOVOCATH IV CATHETER
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    K Number
    K080660
    Device Name
    IV ADMINISTRATION SET
    Manufacturer
    U.S. SAFETY SYRINGES CO., INC.
    Date Cleared
    2008-05-13

    (64 days)

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

    U.S. SAFETY SYRINGES CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The US Safety Syringes IV Administration set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
    Device Description
    The device may include the tubing, a flow regulator, filter, drip chamber, Y port, needless injection port, backflow valve, fluid delivery tubing, connectors between parts of the set and a hollow spike to connect the tubing to an IV bag or medication bag.
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    K Number
    K080665
    Device Name
    NOVOLET
    Manufacturer
    U.S. SAFETY SYRINGES CO., INC.
    Date Cleared
    2008-05-13

    (64 days)

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

    U.S. SAFETY SYRINGES CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Novolet Scalp Vein Blood Collection Set is a winged blood collection needle intended for veinpuncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adaptor from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy.
    Device Description
    Not Found
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    K Number
    K003381
    Device Name
    SHIELDING NEEDLE HOLDER
    Manufacturer
    U.S. SAFETY SYRINGES CO., INC.
    Date Cleared
    2001-04-23

    (174 days)

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

    U.S. SAFETY SYRINGES CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990831
    Device Name
    SUPERGUARD SAFETY SYRINGE
    Manufacturer
    U.S. SAFETY SYRINGES CO., INC.
    Date Cleared
    2000-03-08

    (362 days)

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

    U.S. SAFETY SYRINGES CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SuperGuard™ Safety Syringe is intended as a sterile, single use, disposable syringe, employing an antistick device, for use in the administration of intramuscular and subcutaneous injections.
    Device Description
    The SuperGuard ™ Safety Syringe is a piston syringe combined with a sharps Injury Prevention mechanism that shields the hypodermic needle from exposure and reuse after an initial use.
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