BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SAFE-LOCK UNIVERSAL CONNECTOR (LUER LOCK)

    Reg #: 3004111573 · FEI: 3004111573 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    3004111573
    FEI Number
    3004111573
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1302 Avenue T
    City
    Grand Prairie
    State
    TX
    ZIP
    75050
    Country
    US

    Regulatory Submissions

    510(k) Number
    K822543

    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
    System, Peritoneal, Automatic Delivery FKX

    Proprietary Names

    SAFE-LOCK UNIVERSAL CONNECTOR (LUER LOCK) CAPD SAFE-LOCK® TRANSFER SET (48") Stay¿safe Extension set, 18 in. with Luer-Lock patient connector compatible with stay¿safe® peritoneal dialysis connecto CAPD SAFE-LOCK 8" CATHETER EXTENSION SET WITH MALE AND FEMALE CONNECTOR SAFE-LOCK® 4" CONVERTIBLE EXTENSION SET WITH MALE LUER LOCK AND FEMALE SAFE-LOCK CONNECTOR Stay¿safe Extension set, 6 in. with Luer-Lock patient connector compatible with stay¿safe® peritoneal dialysis connectol Safe-Lock® Spike Transfer Set Adapter ( For Use with Safe-Lock Transfer Set and Compatible with Abbot or Baxter P.D Spik CAPD SAFE-LOCK® 8" CATHETER EXTENSION SET WITH MALE AND FEMALE CONNECTOR AND ROLLER CLAMP Stay¿safe Extension set, 12 in. with Luer-Lock patient connector compatible with stay¿safe® peritoneal dialysis connecto Safe-Lock ® 6" Convertible Extension Set with Female Safe-Lock Connector Male Luer-Lock and Roller Clamp Safe-Lock® Universal connector

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)