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510(k) Data Aggregation

    K Number
    K022502
    Device Name
    INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000
    Manufacturer
    EQUIDYNE SYSTEMS, INC.
    Date Cleared
    2002-09-05

    (38 days)

    Product Code
    KZE
    Regulation Number
    880.5430
    Why did this record match?
    Applicant Name (Manufacturer) :

    EQUIDYNE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The over the counter Injex 30 Needle-Free Insulin Injector System is intended for the subcutaneous iniection of U-100 insulin. The Injex 30 Insulin Ampule is labeled as suitable for administration of 5 to 30 insulin units with a scale in 1 unit increments.
    Device Description
    Equidyne Systems Injex 30 Needle Free Insulin Injector System is a means of administering insulin in the subcutaneous tissue without the use of needles. The needle free injector utilizes a high velocity focused jet of liquid to penetrate the skin and deposit the insulin in the subcutaneous tissue. The process takes place in a fraction of a second. The Injex 30 Needle-Free Insulin Injector System consists of four main components: 1. Iniex 30 Needle-Free Insulin Injector A small re-usable hand held Iniector. 2. Reset Box - A compact re-usable Reset Box used to reset the Injex 30 Needle Free Insulin Injector, 3. Injex 30 Insulin Ampule - A disposable, sterile 30 unit Injex 30 Insulin Ampule that functions like a needle syringe to draw the medication from the medicine bottle or vial using a hand draw with a plunger. Once the Injex 30 Insulin Ampule is loaded into the Injex 30 Needle Free Insulin Injector, the dose is injected into the individual by releasing the Safety and pressing the trigger. 4. Vial Adapter - A disposable, sterile Vial Adapter facilitates the transfer of the insulin from the medicine bottle or vial to the Injex 30 Insulin Ampule. The Injex 30 Needle Free Insulin Injector can deliver variable doses of insulin from 5 to 30 units. The Injex 30 Insulin Ampule scale is in 1 unit increments.
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    K Number
    K022148
    Device Name
    INJEX 30 NEEDLE FREE INJECTION SYSTEM
    Manufacturer
    EQUIDYNE SYSTEMS, INC.
    Date Cleared
    2002-07-23

    (21 days)

    Product Code
    KZE
    Regulation Number
    880.5430
    Why did this record match?
    Applicant Name (Manufacturer) :

    EQUIDYNE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Injex 30 Injector System is designed to deliver various medicines and vaccines by means of a narrow, high velocity jet of fluid which penetrates the surface of the skin and delivers the medicine or vaccine to the body.
    Device Description
    Equidyne Systems Injex 30 Injector System is a means of administering subcutaneous medications without the use of needles. The needle free injector utilizes a high velocity focused jet of liquid to penetrate the skin and deposit the medication in the subcutaneous tissue. The process takes place in a fraction of a second. Needle free injection is useful in a wide range of drug therapy including immunization vaccines, hormones and local anesthetics, as well as the administration of insulin to the diabetic population, where individuals may need a number of injections per day. The Injex 30 Injector system consists of four main components; 1. Injector A small re-usable hand held Injector, 2. Reset Box A compact re-usable Reset Box used to reset and store the Injex 30 Injector, 3. Ampule A disposable, sterile 0.3 ml Ampule that functions like a needle syringe to draw the medication from the medicine bottle or vial using a hand draw with a plunger. Once the Ampule is loaded into the Iniex 30 Iniector, the dose is injected into the individual by releasing the Safety and pressing the trigger. 4. Vial Adapter A disposable, sterile Vial Adapter facilitates the transfer of the medication from the medicine bottle or vial to the Ampule. The Injex 30 Injector can deliver variable doses of fluid medication from 0.05 ml to 0.30 ml.
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    K Number
    K003741
    Device Name
    JET SYRINGE MODEL-100500
    Manufacturer
    EQUIDYNE SYSTEMS, INC.
    Date Cleared
    2001-06-01

    (179 days)

    Product Code
    KZE
    Regulation Number
    880.5430
    Why did this record match?
    Applicant Name (Manufacturer) :

    EQUIDYNE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K003864
    Device Name
    INJEX 50 SYSTEM
    Manufacturer
    EQUIDYNE SYSTEMS, INC.
    Date Cleared
    2001-03-06

    (83 days)

    Product Code
    KZE
    Regulation Number
    880.5430
    Why did this record match?
    Applicant Name (Manufacturer) :

    EQUIDYNE SYSTEMS, INC.

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

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