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510(k) Data Aggregation

    K Number
    K020500
    Device Name
    UNIVEC BIFURCATED SLIDING SHEATH SYRINGE
    Manufacturer
    UNIVEC, INC.
    Date Cleared
    2002-03-19

    (33 days)

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

    UNIVEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Univec Bifurcated Sliding Sheath Syringe is a safety version of a bifurcated needle attached to a syringe barrel with the Univec Sliding Sheath Syringe mechanism. The Univec Sliding Sheath mechanism is used to aid in the prevention of needle stick injuries. This device is used in the same manner as a standard Bifurcated Needle to deliver vaccine or allergen to the patient.
    Device Description
    The Univec Bifurcated Sliding Sheath Syringe is a safety version of a bifurcated needle attached to a syringe barrel with the Univec Sliding Sheath Syringe mechanism.
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    K Number
    K993996
    Device Name
    UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
    Manufacturer
    UNIVEC, INC.
    Date Cleared
    2000-07-17

    (236 days)

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

    UNIVEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UNIVEC Sliding Sheath Syringe (K993996) is an Active Safety Feature for a hypodermic syringe. The Sliding Sheath Mechanism is used with a traditional disposable syringe or the Univec Auto-Destruct syringe. The Univec Sliding Sheath Syringe is used to aid in the prevention of needle stick injuries. After an injection, the shield is easily moved from an unextended to an extended position with one hand so that the needle tip is covered by a 360 degree enclosure. The scale is printed on the barrel in a way that allows the Healthcare worker to read through the sheath or from the backside of the sheath.
    Device Description
    Not Found
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    K Number
    K000747
    Device Name
    UNIVEC TWO PIECE SYRINGE
    Manufacturer
    UNIVEC, INC.
    Date Cleared
    2000-06-08

    (93 days)

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

    UNIVEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961877
    Device Name
    PISTON SYRINGE
    Manufacturer
    UNIVEC, INC.
    Date Cleared
    1996-08-07

    (89 days)

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

    UNIVEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UNIVEC Nonreusable Locking Syringe with Coupling Assembly can be used by health care professionals, diabetics and other persons for injection of insulin, tuberculin, immunization serum, and other injectible medications.
    Device Description
    The UNIVEC Nonreusable Syringe with Coupling Assembly provides a single use function. This assembly, inserted between the syringe plunger and the syringe rubber stopper, will decouple the plunger from the stopper (and disable the syringe) after injecting one dosage of serum. The assembly materials will be fabricated from the same polypropylene as the syringe.
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    K Number
    K933469
    Device Name
    UNIVEC NON-REUSABLE SYRINGE
    Manufacturer
    UNIVEC, INC.
    Date Cleared
    1996-04-18

    (1007 days)

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

    UNIVEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This syringe is intended for diabetics who inject insulin and healthcare professionals who inject insulin, tuberculin or immunization serum and other injectible medications.
    Device Description
    The UNIVEC Model 884 Umbrella Nonreusable Syringe is a sterile piston syringe with 1 cc or 0.5 cc capacitivs fabricated of polypropylene. It has a locking device made of the same polypropylene material. The "umbrella" describes the locking mechanism which emulates the shape and functioning of an umbrella. Functioning in the traditional manner, this syringe is capable of aspirating and mixing various serums in its barrel by health practitioners and individuals for subsequent injection. It can be locked or prevented from further use by depressing the plunger toward the foward end of the barrel (and past noticeable resistance) in order to activate the locking device. Further use of the syringe is thus prevented.
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