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510(k) Data Aggregation

    K Number
    K090917
    Device Name
    SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
    Manufacturer
    BAXA CORP.
    Date Cleared
    2010-02-19

    (324 days)

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

    BAXA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SureConnect Closed Drug Reconstitution and Transfer System is a closed system to be used by pharmacists or other healthcare professionals to prepare and administer drugs, including cytotoxic drugs, for intravenous infusion or injection.
    Device Description
    Not Found
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    K Number
    K070163
    Device Name
    SWABBABLE CAP, MODEL 60205
    Manufacturer
    BAXA CORP.
    Date Cleared
    2007-08-03

    (198 days)

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

    BAXA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Swabbable Cap provides temporary aseptic closure of the male luer connector of the IV tubing while disconnected from the patient, replacing the need for disposable caps to maintain aseptic procedure. The device is designed to be permanently attached to an IV administration set and used over the life of the administration set.
    Device Description
    Provides temporary aseptic closure of the male luer connector of the IV tubing while disconnected from the patient, replacing the need for disposable caps to maintain aseptic procedure.
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    K Number
    K062909
    Device Name
    REPEATER PUMP II TUBE SETS
    Manufacturer
    BAXA CORP.
    Date Cleared
    2007-03-09

    (163 days)

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

    BAXA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Repeater Pump II tube set tube sets are fluid transfer tube sets used in conjunction with the Repeater Pump II pharmacy pump in hospital and compounding pharmacies to provide a pathway through which fluid is transferred from one source container into another suitable container.
    Device Description
    The Repeater Pump II tube set provides the fluid pathway, pump cavity, valving, and tube set for the Repeater Pump II system. The tube set and pump platform work together to provide sterile transfer and reconstitution of pharmaceutical liquids. The tube set utilizes a plastic piston to mechanically pump required amounts of fluid from 0.2mL to 10mL with each piston stroke. A plastic pump core works in conjunction with the piston to provide appropriate fluid pathways for the draw and discharge strokes. There are two tube set connections for inlet and outlet fluid pathways. The Repeater Pump II tube set will be available in eight (8) unique configurations to accommodate various source and final container connections.
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    K Number
    K022523
    Device Name
    RAPID-FILL TUBESET, MODEL 90005
    Manufacturer
    BAXA CORP.
    Date Cleared
    2002-08-12

    (13 days)

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

    BAXA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rapid-Fill Tubeset, manufactured by Baxa Corporation, is a fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller containers.
    Device Description
    The Rapid-Fill Tubeset, is a tubeset used in conjunction with the Rapid-Fill pharmacy pump to fill multiple syringes.
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    K Number
    K002705
    Device Name
    EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400
    Manufacturer
    BAXA CORP.
    Date Cleared
    2001-03-28

    (210 days)

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

    BAXA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K983321
    Device Name
    MICROFUSE DUAL RATE INFUSER
    Manufacturer
    BAXA CORP.
    Date Cleared
    1998-10-06

    (14 days)

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

    BAXA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Baxa Corporation MicroFuse™Dual Rate Infuser is intended to be used for the intermittent administration of I.V. medication.
    Device Description
    The Baxa Corporation MicroFuse Dual Rate Infuser, is a battery powered, portable device that automates the injection of the contents of a syringe into a patient. Each MicroFuse has two pre-determined rates that are be preset at the manufacturing facility. These preset rates can not be modified by the user or patient. The MicroFuse is used with a sterile administration set for injecting the medication into a patient. It depresses the plunger of the syringe at a controlled, pre determined rate, delivering the dose in the syringe over an extended period of time. The MicroFuse is offered in a standard dual rate model. Some custom dual rate models with the only difference being the pre-determined infusion rates are also offered. The MicroFuse System consists of the MicroFuse Dual Rate Infuser and a syringe and administration set. Both syringe and administration sets are sterile and disposable. Since only the accessory syringes and administration sets are in the fluid path, the MicroFuse has no patient contact materials. This also means the device is not provided sterile, nor is it sterilized in the field. The accessories have been previously cleared with the predicate device in K933506.
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