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510(k) Data Aggregation

    K Number
    K023890
    Device Name
    PREPARE CARTRIDGE
    Date Cleared
    2003-02-07

    (78 days)

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

    APPRO HEALTHCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Prepare™ Cartridge is used as a drug reservoir and fluid path for administering intravenous, intra-arterial, subcutaneous, epidural, and subarachnoid drugs to a patient's access site using specified infusion pumps and extension sets. For intravenous, intra-arterial, subcutaneous, epidural and subarachnoid administration Prepare™ Cartridge must be used only with SIMS Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps for the infusion of various medicinal solutions. Prepare™ Cartridge is indicated for use in acute and alternate care settings. Alternate care includes, but is not limited to, infusion clinics, nursing homes, and home healthcare.
    Device Description
    Prepare™ Cartridge is designed for use with Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps. The device provides a reservoir for holding up to 100ml of prepared drug and interfaces with various models of SIMS Deltec infusion pumps to provide a pathway from the reservoir to the patient's access site.
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    K Number
    K023769
    Device Name
    PREPARE ADMINISTRATION SET
    Date Cleared
    2002-12-30

    (48 days)

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

    APPRO HEALTHCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Prepare™ Administration Set is intended for the administration of various medical solutions from an IV container to the patient's access catheter and is used only with Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps. Intended for intravenous, intra-arterial, subcutaneous, epidural, and subarachnoid administration. Prepare™ Administration Set is indicated for use in acute and alternate site settings. Alternate sites include, but are not limited to, infusion clinics, nursing homes, and home healthcare.
    Device Description
    Prepare™ Administration Set is designed for use with Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps. The device provides the interface with the pump and a sterile fluid path from an infusion fluid container to a patient's access catheter.
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