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510(k) Data Aggregation

    K Number
    K112863
    Device Name
    ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN
    Date Cleared
    2012-03-29

    (181 days)

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

    ACTA MEDICAL L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To deliver liquid nutrition formula from storage container to an enteral access device (feeding tube)
    Device Description
    Acta Enteral Sets are constructed from flexible, medical grade, Non-DEHP tubing and have various different connectors at each end of the tubing. One configuration may include an Enteral solution container constructed from same PVC material as the tubing with a Christmas tree connector to connect to a gastric tube (or an extension set) or another configuration may simply be an extension set which connects to patient gastric tube to the nutrition liquid delivery system. The following three configurations are most common, however, other configurations may be manufactured based on customer demand. (Further details, photos, drawings provided in Device Description, Section XI) 1. A complete solution delivery system: This consists of, a solution container, integrated delivery set and a Christmas tree connector to connect to the gastric tube or to an extension set 2. Enteral Administration Set: This consists of a delivery set with a spike to connect to a nutrition solution storage container and a Christmas tree connector to connect to gastric tube or an extension set 3. Enteral Extension Set: This consists of flexible PVC tubing set with proximal connector which can accept a standard Christmas tree connector and a distal connector designed to fit a custom gastric tube
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