BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SAFE-LOCK UNIVERSAL CONNECTOR (LUER LOCK)

    Reg #: 1649518 · FEI: 3001236277 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    1649518
    FEI Number
    3001236277
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3125 Wichita Court
    City
    Fort Worth
    State
    TX
    ZIP
    76140
    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)