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510(k) Data Aggregation

    K Number
    K031407
    Device Name
    ROSS EMBRACE ENTERAL PUMP
    Manufacturer
    ROSS PRODUCT DIV. ABBOTT LABORATORIES
    Date Cleared
    2003-05-20

    (15 days)

    Product Code
    LZH
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROSS PRODUCT DIV. ABBOTT LABORATORIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ross Embrace Enteral Pump is intended to control the delivery rate of liquid enteral feeding formulas to adult and pediatric patients requiring long- or short-term enteral nutrition support in hospitals, long term care facilities or homecare settings. The device is intended to deliver standard liquid enteral formulas or reconstituted powdered formulas that have been thoroughly mixed into solution. This device is not labeled or intended for parenteral use.
    Device Description
    Not Found
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    K Number
    K003047
    Device Name
    AMBULATORY ENTERAL NUTRITION PUMP
    Manufacturer
    ROSS PRODUCT DIV. ABBOTT LABORATORIES
    Date Cleared
    2001-06-12

    (256 days)

    Product Code
    LZH
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROSS PRODUCT DIV. ABBOTT LABORATORIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992494
    Device Name
    FLEXIFLO ENTERAL FEEDING TUBE
    Manufacturer
    ROSS PRODUCT DIV. ABBOTT LABORATORIES
    Date Cleared
    1999-08-25

    (30 days)

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

    ROSS PRODUCT DIV. ABBOTT LABORATORIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flexiflo/ROSS Enteral Feeding Tube is intended for nasoenteric placement into the stomach or small bowel. The tube functions as a conduit to facilitate enteral feeding, and may be used in pediatric, adult or elderly patients who cannot consume an adequate diet orally. This device is also indicated for small bowel feeding of patients with a functioning gut who require short- to moderate-term feeding support, such as post-trauma patients, post-surgical patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exists, or may result, secondary to an underlying disease or condition. The tube may also be used for gastric decompression or evacuation of gastric contents.
    Device Description
    Not Found
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    K Number
    K990863
    Device Name
    MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE
    Manufacturer
    ROSS PRODUCT DIV. ABBOTT LABORATORIES
    Date Cleared
    1999-04-06

    (21 days)

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

    ROSS PRODUCT DIV. ABBOTT LABORATORIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flexiflo PolyG Gastrostomy Tube is intended for gastric placement through a mature gastrocutaneous fistula, or one created during a Stamm or Witzel procedure. The tube functions as a conduit to facilitate enteral feeding, and may be used in pediatric, adult or elderly patients who cannot consume an adequate diet orally. Enteral feeding may be indicated for patients with a functioning gut who require short- to long-term feeding support, such as post-trauma patients, post-surgical patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exists, or may result, secondary to an underlying disease or condition. The tube may also be used for gastric decompression or evacuation of gastric contents.
    Device Description
    Modification to FlexiFlo PolyG® Gastrostomy Tube
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