BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Arrow Select Kits

    Reg #: 1721686 · FEI: 1721686 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1721686
    FEI Number
    1721686
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2400 Airport Rd
    City
    Santa Teresa
    State
    NM
    ZIP
    88008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K071538

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ

    Proprietary Names

    Arrow Select Kits Arrow® Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip®, ARROWg+ard Blue PLUS® Cathet Arrow® Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip®, ARROWg+ard Blue PLUS® Cath Arrow® Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip®, ARROWg+ard Blue PLUS® Cathe Arrow® Vessel Catheterization Kit CVC KIT: 3-L 7 FR X 6" (16 CM) AM/AT PI MDL 1-L: 4.5FR X 15CM HEMODIALYSIS KIT: 2-L 12 FR X 25 CM CVC/PSI KIT: 2-LUMEN 8 FR X 6" (16 CM)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)