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510(k) Data Aggregation

    K Number
    K110023
    Device Name
    INFUSION ADAPTER C100
    Manufacturer
    CARMEL PHARMA AB.
    Date Cleared
    2011-04-12

    (99 days)

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

    CARMEL PHARMA AB.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indication for use is admixing of drug into an IV container and administration/transfer of drug from the container to an external IV line, while minimizing exposure to potentially hazardous drugs aerosols and spills that can occur during the admixing, administration and disposal process.
    Device Description
    The Injector is a sterile device for single-use within the PhaSeal® closed transfer device system for preparation and administration of parenteral drugs.
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    K Number
    K092782
    Device Name
    INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,
    Manufacturer
    CARMEL PHARMA AB.
    Date Cleared
    2009-12-07

    (88 days)

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

    CARMEL PHARMA AB.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indication for use of the PhaSeal system and included components are reconstitution and transfer of drug solutions from one container to another while minimizing exposure to potentially hazardous drugs aerosols and spills that can occur during the reconstitution, administration and disposal process.
    Device Description
    The Injector and Connector is a sterile device for single-use within the PhaSeal® closed system drug transfer device for preparation and administration of parenteral drugs.
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    K Number
    K090634
    Device Name
    PHASEAL PROTECTOR P14, P21, P28 AND P50
    Manufacturer
    CARMEL PHARMA AB.
    Date Cleared
    2009-03-23

    (14 days)

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

    CARMEL PHARMA AB.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indication for use is reconstitution and transfer of drug solutions from one container to another while minimizing exposure to potentially hazardous drugs aerosols and spills that can occur during the reconstitution, administration and disposal process.
    Device Description
    The single lumen docking station of the Protector is fitted to the drug vial for the parenteral drug. The Injector is connected to the Protector and liquid transfer takes place through tightly fitting elastomeric double membranes to minimize leakage during reconstitution, administration and disposal processes. The Protector equilibrates the pressure difference which occurs when fluid or air is added to, or removed from the drug vial.
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    K Number
    K060866
    Device Name
    PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS
    Manufacturer
    CARMEL PHARMA AB.
    Date Cleared
    2006-04-28

    (29 days)

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

    CARMEL PHARMA AB.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Y-site Line serves as the port for IV administration with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Y-site Line has a built in Connector which makes it possible to administer drugs into the patient using the sealed double membrane technique.
    Device Description
    PhaSeal is a closed system for handling of parenteral drugs where the component devices are dedicated to each other to create the system. These single use devices are designed to promote safe handling of medications, particularly cytotoxic drugs. Leakage of drug into the environment is effectively avoided during all three phases of drug handling when the PhaSeal system is used: the preparation of the drug, the administration of the drug to the patient, and waste handling. All drug transferring utilizes a double membrane technique. Each component device is sealed off with an elastomeric membranes are joined together and transfer is made via a specially cut injection cannula. When the component devices of the system are separated after transfer, the membranes act as tight seals that prevent leakage. The Y-site Line serves as the port for IV administration with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Y-site Line has a built in Connector which makes it possible administer drugs into the IV line of the patient using the PhaSeal Injector. Liquid transfer takes place through tightly fitting elastomeric membranes to minimize exposure to potentially hazardous drug aerosols and spills that occur during the administration and disposal processes.
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    K Number
    K023747
    Device Name
    PHASEAL
    Manufacturer
    CARMEL PHARMA AB.
    Date Cleared
    2002-11-15

    (7 days)

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

    CARMEL PHARMA AB.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infusion Adapter serves as a the connecting part between the IV bag and an external IV line (e.g. IV regulators). The Infusion Adapter has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed PhaSeal double membrane technique.
    Device Description
    PhaSeal is a closed system for handling of parenteral drugs where the component devices are dedicated to each other to create the system. These single use devices are designed to promote safe handling of medications, particularly cytotoxic drugs. Leakage of drug into the environment is effectively avoided during all three phases of drug handling when the PhaSeal system is used: the preparation of the drug, the administration of the patient, and waste handling. All drug transferring utilizes a patented double membrane technique. Each component device is sealed off with an elastomeric membranes are joined together and transfer is made via a specially cut injection cannula. When the component devices of the system are separated after transfer, the membranes act as tight seals that prevent leakage.
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    K Number
    K001368
    Device Name
    PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER
    Manufacturer
    CARMEL PHARMA AB.
    Date Cleared
    2000-05-12

    (11 days)

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

    CARMEL PHARMA AB.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K980381
    Device Name
    PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO
    Manufacturer
    CARMEL PHARMA AB.
    Date Cleared
    1998-03-03

    (29 days)

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

    CARMEL PHARMA AB.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PhaSeal® closed system for the preparation and administration of parenteral drugs PhaSeal Infusion Adapter - Intravascular Administration Set: The Infusion Adapter serves as the connecting part between the IV bag and an external IV line. (Example IV regulators.) The Infusion Adapter has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed double membrane technique. PhaSeal Protection Cap - Special accessories: The Protection Cap is intended to be used as a mechanical cover for the membrane in the bayonet fitting of PhaSeal devices The Protection Cap mates with the other PhaSeal components equipped with the bayonet fitting. One end of the Protection Cap has a male bayonet fitting and in the other a female bayonet fitting. PhaSeal Secondary Set - Intravascular Administration Set: The Secondary Set is a non-vented infusion set used when drug is handled as an admixture and is administered via Intravenous infusion. The Secondary Set has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed PhaSeal technique. PhaSeal Extension Set - Intravascular Administration Set: The Extension Set serves as the port for bolus injection with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Extension Set has a built in Connector which makes it possible inject drugs into the IV line of the patient using the sealed double membrane technique.
    Device Description
    PhaSeal is a closed system for preparation and administration of parenteral drugs where the component devices are dedicated to each other to create the system. These single use devices are designed to promote safe handling of medications, particularly cytotoxic drugs. Leakage of drug into the environment is effectively avoided during all three phases of drug handling when the PhaSeal system is used: the preparation of the administration of the drug to the patient, and waste handling. All drug transferring utilizes a patented double membrane technique. Each component devices is sealed off with an elastomeric membrane cover. The membranes are joined together and transfer is made via a specially cut injection cannula. When the component devices of the system are separated after transfer, the membranes act as tight seals that prevent leakage.
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