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510(k) Data Aggregation

    K Number
    K993832
    Device Name
    AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10
    Date Cleared
    2000-02-09

    (89 days)

    Product Code
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    TANDEM MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AutoDose Infusion system is intended for sequential infusion of predetermined volumes of intravenous solutions including 0.9% Sodium Chloride Injection, (NaCl), and Heparin Lock Flush Solution, USP solutions.
    Device Description
    The AutoDose Infusion System was designed to infuse Intravenous solutions of predetermined volumes in a predetermined order based on the configuration of the disposable bag. The system is capable of infusing Intravenous (IV) solutions of the following volumes in this order: Chamber 1 <= 10 mls., Chamber 2 ~ 25 – 120 mls, Chamber 3 <= 10 mls. A Pharmacist may decide to use the AutoDose Infusion System with an AutoDose Bag filled with 0.9% Sodium Chloride Injection and Heparin Lock Flush Solutions, USP in conjunction with an Administration IV fluid. In this configuration, the AutoDose would deliver the IV fluids using the deliver regimen, commonly known as SASH: (Saline, Administration, Saline, Heparin) and eliminate the need to use needles, syringes and access the IVAD (Intravenous Access Device) multiple times. When the Pharmacist chooses to use the AutoDose Infusion system in this manner, an empty AutoDose Bag is filled with Saline and Heparin solutions drawn and prepared from the Pharmacy stores. After the prescription is filled with the main medication (i.e. Administration solution), the solutions are administered to the patient using the AutoDose Infusion System following the Directions for Use.
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    K Number
    K990889
    Device Name
    AUTODOSE INFUSION SYSTEM
    Date Cleared
    1999-06-03

    (78 days)

    Product Code
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    TANDEM MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AutoDose Infusion System is intended for general use infusion of predetermined volumes of intravenous solutions.
    Device Description
    The AutoDose Infusion System is a general use infusion system that is intended to infuse intravenous solutions of predetermined volumes in an order based on the AutoDose Bag configuration. It is intended that this system will infuse multiple intravenous solutions of predetermined volumes without user interaction. The system is comprised of the AutoDose, a mechanical roller device design in conjunction with the AutoDose Bag, a multiple chambered IV container, and the AutoDose Bag Administration Set. The single use multiple chambered IV container is designed to fit within the reusable AutoDose device with the end user pushing a start button once the AutoDose Bag Administration Set has been connected to the patient's indwelling access device. The AutoDose Bag Administration Set size will determine the system flow rate and will be offered in rates of 50 ml/hr, 100 ml/hr, and 200 ml/hr. It is intended that the AutoDose Bag be provided empty and sterile to the end user. The AutoDose Bag can then be appropriately filled on the order of a physician by a pharmacy. The filling of the AutoDose Bag is performed using standard procedures, equipment and the AutoDose Filling Fixture. The AutoDose Filling Fixture is a tool developed to hold the AutoDose Bag for the pharmacist during the filling process. A clamp is automatically activated by the AutoDose Filling Fixture to securely close the bag after it has been filled. The AutoDose Infusion System has been designed to simplify user interaction in the administration of multiple solutions safely with a reduction of a number of steps and a number of supplies typically used by healthcare providers. The AutoDose Bag and the AutoDose Bag Administration Set will be sterilized per AAMI guidelines to a 10 6 sterility assurance level (SAL). Pyrogenicity will be LAL assessed per production lot in accordance with USP guidelines.
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