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510(k) Data Aggregation

    K Number
    K140730
    Device Name
    VIAL2BAG DIRECT CONNECT
    Manufacturer
    MEDIMOP MEDICAL PROJECTS, LTD.
    Date Cleared
    2014-06-12

    (80 days)

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

    MEDIMOP MEDICAL PROJECTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vial2Bag™ Direct Connect is indicated to serve as a connecting part between the IV line. The integrated vial adapter makes it possible to reconstitute and admix drugs from a vial into the infusion solution.
    Device Description
    The proposed device, Vial2Bag" Direct Connect, consists of the Vial2Bag" piercing spike and cover, the twist-off connector and an integrated Vial Adapter for access to the drug/solution vial. It does not contain any medicinal substances and can be used with standard drug vials. It is intended for use in healthcare facilities or in home environment by a care-giver to aid and support prescribed treatment and therapy.
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    K Number
    K130179
    Device Name
    MP VIAL ADAPTER 13MM
    Manufacturer
    MEDIMOP MEDICAL PROJECTS, LTD.
    Date Cleared
    2013-08-08

    (195 days)

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

    MEDIMOP MEDICAL PROJECTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Allow needle-free withdrawal, reconstitution and transfer of Bravelle® (urofolitropin for injection, purified) and/or Menopur® (menotropins for injection, USP) and diluent from vials into an injection syringe for administration on a single patient during a single procedure.
    Device Description
    The device is a needless transfer device which enables reconstitution of one diluent vial and up to five vials of the fertility drugs Bravelle®, or Menopur® manufactured by Ferring using one MP Vial Adapter 13 mm. The device is a single use sterile device which will be included into Ferring Pharmaceutical's Bravelle® and/or Menopur® drug kits to assist in the reconstitution of these lyophilized drugs for injection using one reconstitution diluent vial.
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    K Number
    K132040
    Device Name
    VIAL CONNECTOR 13MM CLOSED COLLAR
    Manufacturer
    MEDIMOP MEDICAL PROJECTS, LTD.
    Date Cleared
    2013-07-31

    (29 days)

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

    MEDIMOP MEDICAL PROJECTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The proposed device is indicated for the transfer and mixing of drugs contained in a vial.
    Device Description
    The proposed device, Vial Connector 13 mm Closed Collar, is intended for use in healthcare facilities or in home environment by the patient or care-giver to aid and support prescribed treatment and therapy. The proposed device consists of two integrated parts, the first part is the 13mm vial connector body intended to be attached to a standard 13 mm drug vial neck and a male luer connection. The vial connector body contains the single lumen piercing spike and an assembled 5μm fluid path filter (Versapor® Hydrophilic membrane on a HDPE disc). The second part of the device is the closed collar which restricts the connection of the vial connector to standard 13 mm vials with a body diameter of up to 15 mm. The two integrated parts are injection molded as one single device. The proposed device does not contain any medicinal substances.
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    K Number
    K122023
    Device Name
    MIXJECT WITH SPRAY HEAD
    Manufacturer
    MEDIMOP MEDICAL PROJECTS, LTD.
    Date Cleared
    2012-10-04

    (85 days)

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

    MEDIMOP MEDICAL PROJECTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Transfer, mixing and topical spray application / delivery of drugs with a viscosity up to 4.7cP contained in vials
    Device Description
    The Medimop Mixject with Spray Head device enables injection of a diluent into a drug vial connected to the Dispensing pin (Vial adapter), for reconstitution and aspiration of the reconstituted drug into a syringe attached to the luer-lock end of the body. The vial and the Dispensing pin (Vial adapter) can be removed by turning the Dispensing pin (Vial adapter). The removal of the Dispensing pin (Vial adapter) turns the turning core from the aspiration position to the fixed spray position allowing spray application / delivery of the drug onto the desired surface.
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    K Number
    K072511
    Device Name
    SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM
    Manufacturer
    MEDIMOP MEDICAL PROJECTS, LTD.
    Date Cleared
    2007-12-13

    (98 days)

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

    MEDIMOP MEDICAL PROJECTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Swabable Vial Adapter is indicated to allow multiple needleless accesses to an injection medication vial for the purpose of facilitating the withdrawal or addition of dugs/solutions from or to the vial
    Device Description
    The Swabable Vial Adapter is designed for the purpose of allowing safe and easy transfer of liquid drugs from and into vials. The product allows quick transfer of the contents of a syringe, typically containing diluents, into a drug (in the form of powder) vial and easy aspiration of the dissolved drug back into a syringe, or any other standard accessory. The Swabable Vial Adapter is an assembly of three components. A Hydrophobic medium (optional) is attached to the "body" with the double lumen spike (penetrating the rubber stopper) and a cap (with a luer connection) is attached to the sub-assembly.
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    K Number
    K072759
    Device Name
    VIAL2BAG
    Manufacturer
    MEDIMOP MEDICAL PROJECTS, LTD.
    Date Cleared
    2007-12-13

    (76 days)

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

    MEDIMOP MEDICAL PROJECTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vial2Bag is indicated to serve as a cornecting part between the IV bag and an external IV Line. The Vial2Bag has a built in connector which makes it possible to admix drugs into the infusion solution using a Swabable Valve.
    Device Description
    The Vial2Bag is designed to serve as a connecting part between the IV bag and an external IV Line while allowing safe and easy transfer of drugs/diluents from and into an IV bag. The product allows quick transfer of the contents of a syringe or vial into an IV bag. The Vial2Bag is an assembly of three components a spike, a Swabable valve and a twist-off.
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    K Number
    K062482
    Device Name
    VENTED VIAL ADAPTER TRANSFER DEVICE
    Manufacturer
    MEDIMOP MEDICAL PROJECTS, LTD.
    Date Cleared
    2006-11-03

    (71 days)

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

    MEDIMOP MEDICAL PROJECTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Transfer and Mixing of drugs contained in vials
    Device Description
    The Vented Vial Adapter Transfer Device is designed for the purpose of allowing safe and easy transfer of liquid drugs from and into vials while keeping the process in pressure equilibrium with the ambient pressure. The product allows quick transfer of the contents of a syringe, typically containing diluents, into a drug (in the form of powder) vial and easy aspiration of the dissolved drug back into a syringe, or any other standard accessory. The Vented Vial Adapter Transfer Device is an assembly of three components. A Hydrophobic medium (optional) is attached to the "body" with the double lumen spike (penetrating the rubber stopper) and a cap (with a lucr connection) is attached to the subassembly.
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    K Number
    K031861
    Device Name
    MIX2VIAL TRANSFER DEVICE
    Manufacturer
    MEDIMOP MEDICAL PROJECTS, LTD.
    Date Cleared
    2003-07-29

    (43 days)

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

    MEDIMOP MEDICAL PROJECTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mix2vial Transfer Device is intended for transferring and mixing drugs contained in two vials.
    Device Description
    Not Found
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    K Number
    K001831
    Device Name
    NEEDLELESS TRANSFER DEVICE
    Manufacturer
    MEDIMOP MEDICAL PROJECTS, LTD.
    Date Cleared
    2000-07-11

    (25 days)

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

    MEDIMOP MEDICAL PROJECTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001293
    Device Name
    MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE
    Manufacturer
    MEDIMOP MEDICAL PROJECTS, LTD.
    Date Cleared
    2000-05-05

    (11 days)

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

    MEDIMOP MEDICAL PROJECTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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