BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Carefusion5709 (NT) - MaxPlus pressure rated extension set with removable needleless connector

    Reg #: 2032098 · FEI: 3003058448 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    26
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Isomedix Operations, Inc
    Registration Number
    2032098
    FEI Number
    3003058448
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1000 Sarah Pl
    City
    ONTARIO
    State
    CA
    ZIP
    91761
    Country
    US

    Regulatory Submissions

    510(k) Number
    K051499

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    1527821
    Address
    5960 Heisley Rd, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA

    Proprietary Names

    Carefusion5709 (NT) - MaxPlus pressure rated extension set with removable needleless connector Carefusion5709 (NT) - MaxGuard T-connector extension set Carefusion5709 (NT) - MaxGuard multidose vial adaptor Carefusion5709 (NT) - MaxPlus, MaxGuard pressure rated T-connector extension set with needleless connector Carefusion5709 (NT) - MaxGuard pressure rated extension set Carefusion5709 (NT) - MaxGuard, MaxPlus multi-fuse extension set with needleless connector (s) Carefusion5709 (NT) - MaxGuard standard needleless connector Carefusion5709 (NT) - MaxPlus pressure rated extension set with needleless connector Carefusion5709 (NT) - MaxGuard pressure rated extension set with Y-site(s) Carefusion5709 (NT) - MaxGuard extension set with needleless Y-site(s) Carefusion5709 (NT) - MaxGuard pressure rated T-connector extension set with needleless connector Carefusion5709 (NT) - MaxGuard T-connector extension set with needleless connector Carefusion5709 (NT) - MaxPlus extension set with needleless connector and y-site Carefusion5709 (NT) - MaxPlus Extension Set Carefusion5709 (NT) - MaxPlus presssure rated extension set with needleless connector and y-site Carefusion5709 (NT) - MaxGuard extension set with standard needleless connector Carefusion5709 (NT) - MaxGuard, MaxPlus multi-fuse extension set with needleless connector(s) Carefusion5709 (NT) - MaxGuard multi-fuse extension set with needleless connector(s) Carefusion5709 (NT) - MaxPlus Needleless Connector Carefusion5709 (NT) - MaxPlus, MaxGuard T-connector extension set with needleless connector Carefusion5709 (NT) - MaxGuard single dose vial access spike Carefusion5709 (NT) - MaxGuard Extension Set with Filter Carefusion5709 (NT) - MaxGuard extension set with Y-site(s) Carefusion5709 (NT) - MaxGuard pressure rated T-connector extension set Carefusion5709 (NT) - MaxGuard Extension Set Carefusion5709 (NT) - MaxPlus, MaxGuard multi-fuse extension set with needleless connector(s)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)