BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ameritus ENFit(r) Enteral Syringes

    Reg #: 2080225 · FEI: 2080225 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KENTEC MEDICAL, INC.
    Registration Number
    2080225
    FEI Number
    2080225
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    17871 FITCH
    City
    Irvine
    State
    CA
    ZIP
    92614
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162188

    Owner / Operator

    Firm Name
    KENTEC MEDICAL, INC.
    Operator Number
    2080225
    Address
    17871 FITCH, --
    City
    Irvine
    State
    CA
    Postal Code
    92614
    Country
    US

    Products

    Device Name Product Code
    Enteral Syringes With Enteral Specific Connectors PNR

    Proprietary Names

    Ameritus ENFit(r) Enteral Syringes

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198