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510(k) Data Aggregation

    K Number
    K240164
    Device Name
    NovaLine SP-C35 Transducer Protector (956007)
    Manufacturer
    Bain Medical Equipment (Guangzhou) Co., Ltd.
    Date Cleared
    2024-06-28

    (158 days)

    Product Code
    FIB
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NovaLine SP-C35 Transducer Protector is a single-use, disposable, prescription device intended for use as a protective device for pressure monitors and to help prevent contamination of the fluid pathway in hemodialysis delivery systems.
    Device Description
    The NovaLine SP-C35 Transducer Protector consists of a plastic housing that contains a hydrophobic filter with a reference pore size of 0.2 µ m. The housing has male and female luer lock connectors that allow its attachment between a blood tubing set and the pressure monitor on a hemodialysis machine. The NovaLine SP-C35 Transducer Protector is to be used as protective device for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.2 ↓ m hydrophobic filter helps prevent cross-contamination by viruses, bacterial and particulate matter while preventing the flow of fluids to the hemodialysis machine pressure monitor. The devices are packaged sterile and labeled for single use only. The proposed devices are provided in sterile condition, it is subject to e-beam radiation sterilization prior to release to achieve a Sterility Assurance Level (SAL) of 10-6.
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    K Number
    K072988
    Device Name
    NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Date Cleared
    2008-02-21

    (121 days)

    Product Code
    FIB
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nipro Transducer Protector TP-SURE is a single-use, disposable, prescription device intended for use as a protective device for pressure monitors and to help prevent contamination of the fluid pathway in hemodialysis delivery systems.
    Device Description
    The Nipro Transducer Protector TP-SURE consists of a plastic housing that contains a hydrophobic filter with a reference pore size of 0.1 um. The housing has male and female luer lock connectors that allow its attachment between a blood tubing set and the pressure monitor on a hemodialysis machine. The TP-SURE is to be used as protective device for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.1 µm hydrophobic filter helps prevent cross-contamination by viruses, bacterial and particulate matter while preventing the flow of fluids to the hemodialysis machine pressure monitor. The devices are packaged sterile and labeled for single use only. There is no ability to clean and reuse these devices. They are restricted for sale by or on the order of a physician.
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    K Number
    K001971
    Device Name
    HEMODIALYSIS TUBING SETS
    Manufacturer
    OFI BIOMEDICA S.P.A.
    Date Cleared
    2001-05-24

    (330 days)

    Product Code
    FIB
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010264
    Device Name
    NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
    Manufacturer
    NIPRO MEDICAL CORP.
    Date Cleared
    2001-04-27

    (88 days)

    Product Code
    FIB
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001465
    Device Name
    NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
    Manufacturer
    NIPRO MEDICAL CORP.
    Date Cleared
    2000-12-05

    (209 days)

    Product Code
    FIB
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003445
    Device Name
    FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Date Cleared
    2000-12-01

    (25 days)

    Product Code
    FIB
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000702
    Device Name
    BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Date Cleared
    2000-06-07

    (98 days)

    Product Code
    FIB
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K983076
    Device Name
    MEDISYSTEMS TRANSDUCER PROTECTOR
    Manufacturer
    MEDISYSTEMS CORP.
    Date Cleared
    1998-11-25

    (84 days)

    Product Code
    FIB
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medisystems Transducer Protectors are indicated for use as protective devices for pressure monitors on hemodialysis machines as well as to help protect the sterility of the blood tubing fluid pathway. The filter helps prevent cross-contamination by viruses, bacteria, and other particulate matter while preventing the flow of fluids to the hemodialysis machine's pressure transducer.
    Device Description
    Medisystems Transducer Protectors are designed to be used as protective devices for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.2 um hydrophobic filter helps prevent cross-contamination by viruses, bacteria and particulate matter while preventing the flow of fluids to the hemodialysis machine pressure monitor. The technical characteristics of the device consist of a filter housing that contains a 0.2 um hydrophobic filter. The combination of the pore size and hydrophobic nature of the filter also prevents the flow of fluids, viruses, bacteria, and particulate matter into the pressure monitor at pressures lower than the rated pressure of the device.
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    K Number
    K964337
    Device Name
    BETTER-BLADDER (BB)
    Manufacturer
    CIRCULATORY TECHNOLOGY, INC.
    Date Cleared
    1997-05-23

    (204 days)

    Product Code
    FIB
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Better-Bladder™ is a device that isolates pressure transducers from blood contact when measurements of blood pressure in extracorporeal circuits are made. The noninvasive pressure obtained. with the BB can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during routine bypass procedures.
    Device Description
    The Better-Bladder™ is a device that isolates pressure transducers from blood contact when measurements of blood pressure in extracorporeal circuits are made. The noninvasive pressure obtained. with the BB can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during routine bypass procedures.
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    K Number
    K970536
    Device Name
    MEDISYSTEMS TRANDUCER PROTECTOR
    Manufacturer
    MEDISYSTEMS CORP.
    Date Cleared
    1997-05-12

    (89 days)

    Product Code
    FIB
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medisystems Transducer Protectors are single use, disposable prescription devices intended for use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway.
    Device Description
    Medisystems Transducer Protectors are designed to be used as protective devices for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.2 µm hydrophobic filter helps prevent cross-contamination by bacteria and particulate matter while preventing the flow of fluids to the machine pressure monitor at pressures less than 600 mmHg.
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