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510(k) Data Aggregation

    K Number
    K142792
    Device Name
    AbbVie NJ
    Manufacturer
    ABBVIE INC.
    Date Cleared
    2015-01-14

    (110 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABBVIE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AbbVie NJ is intended to provide short-term enteral access for administration of medication to the small intestine. The AbbVie NJ is indicated for the administration of the medication DUOPA (carbidopa and levodopa enteral suspension).
    Device Description
    The AbbVie NJ (List Number 62903) is a 10 FR, 152 cm, naso-jejunal (NJ) tube made of white radiopaque polyurethane. The distal coiled end region and bolus tip are coated with a water activated lubricant. The AbbVie NJ includes a silicone coated stainless steel Stylet. The kit is supplied sterile (ethylene oxide). The AbbVie NJ is inserted through the nose and advanced into the small intestine for administration of medication in a home and/or healthcare facility environment. The Stylet is used to aid insertion and is removed once the tube is in place.
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    K Number
    K142793
    Device Name
    AbbVie PEG
    Manufacturer
    AbbVie Inc.
    Date Cleared
    2015-01-14

    (110 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    AbbVie Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AbbVie PEG is intended to provide long-term enteral access for administration of medication to the small intestine when used in conjunction with the AbbVie J, intestinal tube. As needed, enteral nutrition may be administered directly to the stomach in parallel with medication delivery to the intestine. The AbbVie PEG is indicated for the administration of the medication DUOPA (carbidopa and levodopa enteral suspension).
    Device Description
    The AbbVie PEG is a percutaneous endoscopic gastrostomy (PEG or gastric) tube, either 15 FR (List Number 62910) or 20 FR (List Number 62912) and 35 cm in length. The product components include the following: - AbbVie PEG Tube (polyurethane) . - External Fixation Plate (silicone, radio-opaque) with integrated Tube Clip and ● - Tube Clamp. ● Additionally, the kit includes the following components: - Reel of thread . - Introducer device ● - Puncture cannula with safety (air) valve and ● - Disposable scalpel. ● The kit is supplied sterile (ethylene oxide). The AbbVie PEG is intended to allow the introduction of the AbbVie J intestinal tube for administration of medication in a home and/or healthcare facility environment. The AbbVie PEG is inserted through an incision in the abdominal wall over the stomach. The AbbVie J intestinal tube is placed through the PEG in order to deliver medication to the small intestine.
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    K Number
    K142816
    Device Name
    AbbVie J
    Manufacturer
    ABBVIE INC.
    Date Cleared
    2015-01-14

    (107 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABBVIE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AbbVie J is intended to provide long-term enteral access for administration to the small intestine. The AbbVie J is indicated for the administration of the medication DUOPA (carbidopa enteral suspension).
    Device Description
    The AbbVie J (List Number 62918) is a 9 FR intestinal (J) tube, 120 cm in length. The kit includes: AbbVie J intestinal tube (polyurethane), Guide Wire (Teflon™-coated stainless steel), Y-Connector, Click Adaptor. The kit is supplied sterile (ethylene oxide). The AbbVie J is inserted through the AbbVie PEG with the aid of the guide wire. The guide wire is used to aid insertion and is removed once the tube is in place. The intestinal tube's tip is placed in the small intestine for the administration of medication in a home and/or healthcare facility environment. A Y-Connector and Click Adaptor are included in the AbbVie J kit to connect the AbbVie PEG and intestinal tubes.
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    K Number
    K133087
    Device Name
    ABBVIE PEG
    Manufacturer
    ABBVIE INC.
    Date Cleared
    2014-06-19

    (262 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABBVIE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AbbVie PEG is intended to provide long-term enteral access for administration of medication to the small intestine when used in conjunction with the AbbVie J, intestinal tube. As needed, enteral nutrition may be administered directly to the stomach in parallel with medication delivery to the intestine.
    Device Description
    The AbbVie™ PEG is a percutaneous endoscopic gastrostomy (PEG or gastric) tube, either 15 FR or 20 FR and 35 cm in length. The kit includes the following: AbbVie PEG Tube (polyurethane), Reel of Thread with double thread and Introducer Device, Puncture Cannula with safety (air) valve, Disposable Scalpel, Silicone external Fixation Plate (radio-opaque) with integrated Tube Clip, and Tube Clamp.
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    K Number
    K133129
    Device Name
    ABBVIE NJ
    Manufacturer
    ABBVIE INC.
    Date Cleared
    2014-06-19

    (262 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABBVIE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AbbVie NJ is intended to provide short-term enteral access for administration of medication to the small intestine.
    Device Description
    The AbbVie™ NJ is a 10 FR, 152 cm, naso-jejunal (NJ) tube made of white radiopaque polyurethane. The distal coiled end region and bolus tip are coated with a water activated lubricant. The AbbVie NJ includes a silicone coated Stylet.
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    K Number
    K133096
    Device Name
    ABB VIE J
    Manufacturer
    ABBVIE INC.
    Date Cleared
    2014-06-18

    (261 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABBVIE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AbbVie J is intended to provide long-term enteral access for administration of medication to the small intestine.
    Device Description
    The AbbVie™ J is a 9 FR intestinal (J) tube, 120 cm in length. The kit includes: AbbVie J tube with Teflon™-coated Guide Wire and Blue Guide Wire Lock, Y-Connector, Fixation Screw (blue or violet) with Outer Ring, Click Adaptor consisting of: Click Adaptor Cap and Click Adaptor Connector.
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