BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Arrow® PICC Two-Lumen Peripherally Inserted Central Catheter with Blue FlexTip® Catheter

    Reg #: 1061124 · FEI: 1000512168 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    21
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1061124
    FEI Number
    1000512168
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10821 Withers Cove Park Dr
    City
    Charlotte
    State
    NC
    ZIP
    28278
    Country
    US

    Regulatory Submissions

    510(k) Number
    K042126

    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, Long-Term Greater Than 30 Days LJS

    Proprietary Names

    Arrow® PICC Two-Lumen Peripherally Inserted Central Catheter with Blue FlexTip® Catheter Arrow® Two-Lumen Peripherally Inserted Central Catheter Set with Trimmable, Tapered Catheter Body Arrow® Peripherally Inserted Central Catheter Set with Blue FlexTip® Catheter Arrow® Peel-Away Sheath over 15 Ga. Needle Arrow® PICC Two-Lumen Peripherally Inserted Central Catheter Arrow® Spring-Wire Guide Arrow® PICC Peripherally Inserted Central Catheter Set with Blue FlexTip® Catheter Arrow® Two-Lumen PICC Kit with Blue FlexTip® Catheter Arrow® Peel-Away Sheath over Needle Sheath Arrow® PICC Two-Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip® Catheter Arrow® Peripherally Inserted Central Catheter with Trimmable Catheter Arrow® PICC Peripherally Inserted Central Catheter with Blue FlexTip® Arrow® PICC Peripherally Inserted Central Catheter Set with Trimmable Catheter Arrow® Trimmable PICC Arrow® PICC Kit Arrow® Peripherally Inserted Central Catheter Kit with Trimmable Catheter Arrow® Peripherally Inserted Central Catheter with Blue FlexTip® Catheter Arrow® Two-Lumen Peripherally Inserted Central Catheter Arrow® Peripherally Inserted Central Catheter Set with Trimmable Catheter Arrow® Peel-Away Sheath over 17 Ga. Needle Arrow® Peripherally Inserted Central Catheter Kit with Blue FlexTip® Catheter

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)