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510(k) Data Aggregation

    K Number
    K203674
    Device Name
    B Dispensing Line
    Manufacturer
    Date Cleared
    2021-09-27

    (285 days)

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

    AEA srl

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    B Recon Line is intended for transfer of solvent from IV bag to a vial with powder drug to be reconstituted, through the APOTECAbag automated system. B Double Filling Line is intended for the transfer of solvent from a bag and liquid drug from a vial to a bag through the APOTECAbag automated system. B Filling Line is intended for transfer of drug from a vial to a bag through the APOTECAbag automated system. B Recon Line with needle is intended for transfer of solvent from a bag to a vial with powder drug to be reconstituted, through the APOTECAbag automated system. B Double Filling Line with vial needle is intended for the transfer of solvent from a bag and liquid drug from a bottle to a bag through the APOTECAbag automated system. B Filling Line for bag is intended for transfer of drug from a bag to another bag through the APOTECAbag automated system. B Dispensing Line devices are only to be used with APOTECAbag pharmacy compounding device. These devices are not to be used for the compounding of chemotherapy and oncology drugs.
    Device Description
    B Dispensing Line is a disposable medical device used for the transfer of liquids from an initial container to a final one, by means of the action of a peristaltic pump. It is a sterile tube, with sections designed to be inserted in peristaltic pump and with specific terminal connectors for the connection of the device with the different containers. The tube section to be inserted in the peristaltic pump presents a larger diameter than the other sections of tube. The device is intended to be used with the purpose of pharmacy compounding in the automated system APOTECAbag. The device is manufactured with biocompatible materials and it is provided sterile by EO sterilization method.
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    K Number
    K192770
    Device Name
    S dispensing line
    Manufacturer
    Date Cleared
    2020-12-17

    (444 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    AEA srl

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The S Dispensing Line is intended for transfer of liquid drug from bag to syringes through the APOTECAsyringe automated system. The device is used inside an automatic system APOTEC Asyringe that tightens the tube with the syringe, while the connection with the bag is done manually. The transfer of liquid takes place by depression through the mechanical action on the piston of the syringe of a manipulator equipped with a gripping device.
    Device Description
    Sdispensinglineisadevice for the transferofiquids, with the purpose of preparation of in drugs. The device is intended to be used with APOTECAsyringe automatic compoundingsystem. Thedeviceissingleuse, sterilizedbyEOandsingle-packagedinablister. The device is not manufactured with natural rubber latex. Medical grade plastics are used, according to ISO 10993 series standards. Sdispensingline is a non-vented infusion setused as a connecting part be rock syringe without hypodermic needle. The tip in contact with the syringe must perfectly by means of a pressure connector (not by screwind). in ordertoavoidloss ofmedication; the connectoris to be assembled atthe endof the line. The short line enables the transfer of drug from a bag to a luer lock syringe through the APOTECAsyringe automated system. The line is intended for the connection of the spike perforator; a check valve prevents the flow back towards thebag.
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    K Number
    K132011
    Device Name
    APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET
    Manufacturer
    Date Cleared
    2014-03-21

    (263 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    AEA SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The APOTECA® Drug Compounding Dosing Device is indicated for use by pharmacists or other healthcare professionals for the preparation of chemotherapy drugs, for the transfer of drug from vials to IV bag for infusion. The drug transfer through the device can be performed manually or through an automatic pharmacy compounding system. The specific assembly configuration of the needle allows a robotic arm to manage the device and an automatic dosing device to transfer drug from a vial to a bag by applying pressure on the syringe plunger. The APOTECA® Drug Compounding Dosing Device is intended for use with APOTECAchemo automatic compounding system or for manual drug compounding. The APOTECA® I.V. Transfer Set is a non-vented infusion set indicated to be used as a connecting part between the IV bag and an external IV line when the drug preparation is performed through an automatic pharmacy compounding system. The APOTECA® I.V. Transfer Set is intended for use with APOTECAchemo automatic compounding system.
    Device Description
    The APOTECA® Drug Compounding Dosing Device and I.V. Transfer Set is a system for preparation and administration of drugs intended for use with APOTECAchemo automatic compounding system. APOTECA® Drug Compounding Dosing Device: a single use piston syringe that consists of a syringe (3ml, 5ml, 10ml, 20ml, 50ml) with a luer lock connector bonded to a needle. The syringe consists of a plastic barrel with a graduated scale, a synthetic rubber stopper and a plastic plunger rod. The needle is a Huber point non-coring needle with 16G thin wall cannula (0.5" plus 0.5" inside the vented hub). The device is not manufactured with natural rubber latex. The device is designed to be handled manually or by automatic pharmacy compounding system for the preparation and admixture of drugs in healthcare establishments. APOTECA® I.V. Transfer Set: a non-vented infusion set used as a connecting part between an IV bag and an external infusion line. The device comprises of the following components: Non-vented spike, Connecting tube, Spike port adaptor with Twist-Off cap and safety membrane, Luer lock adaptor with protective cap.
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