BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CAREFUSION - MaxGuard multi-fuse extension set with needleless connector(s)

    Reg #: 2030598 · FEI: 1000518731 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    29
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Synergy Health AST, LLC
    Registration Number
    2030598
    FEI Number
    1000518731
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9020 Activity Rd Ste D
    City
    SAN DIEGO
    State
    CA
    ZIP
    92126
    Country
    US

    Regulatory Submissions

    510(k) Number
    K051499

    Owner / Operator

    Firm Name
    Synergy Health AST, LLC
    Operator Number
    10028672
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA

    Proprietary Names

    CAREFUSION - MaxGuard multi-fuse extension set with needleless connector(s) CAREFUSION - MaxGuard multidose vial adaptor CAREFUSION - MaxPlus pressure rated extension set with needleless connector CAREFUSION - MaxGuard, MaxPlus multi-fuse extension set with needleless connector (s) CAREFUSION - MaxGuard single dose vial access spike CAREFUSION - MaxPlus presssure rated extension set with needleless connector and y-site CAREFUSION - MaxGuard pressure rated T-connector extension set with needleless connector CAREFUSION - MaxPlus extension set with needleless connector and y-site CAREFUSION - MaxGuard, MaxPlus multi-fuse extension set with needleless connector(s) CAREFUSION - MaxPlus, MaxGuard multi-fuse extension set with needleless connector(s) CAREFUSION - MaxGuard Extension Set CAREFUSION - MaxPlus pressure rated extension set with removable needleless connector CAREFUSION - MaxPlus Extension Set CAREFUSION - MaxGuard extension set with needleless Y-site(s) CAREFUSION - MaxGuard T-connector extension set CAREFUSION - MaxPlus, MaxGuard multi-fuse extension set with needleless connector(s) CAREFUSION - MaxGuard extension set with standard needleless connector CAREFUSION - MaxGuard standard needleless connector CAREFUSION - MaxPlus Needleless Connector CAREFUSION - MaxGuard T-connector extension set with needleless connector CAREFUSION - MaxPlus, MaxGuard pressure rated T-connector extension set with needleless connector CAREFUSION - MaxGuard Extension Set with Filter CAREFUSION - MaxGuard pressure rated extension set with Y-site(s) CAREFUSION - MaxGuard/ Max Plus IV Administration Sets CAREFUSION - MaxGuard pressure rated extension set CAREFUSION - MaxPlus, MaxGuard T-connector extension set with needleless connector CAREFUSION - MaxGuard pressure rated T-connector extension set CAREFUSION - MaxGuard extension set with Y-site(s) Carefusion (SDB) - set, administration, intravascular

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)