BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Single HygieniKit 17151

    Reg #: 1721686 · FEI: 1721686 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    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
    K973501

    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
    Pump, Breast, Powered HGX

    Proprietary Names

    Single HygieniKit 17151 One Hand Dual Breast Pump 17152 One Hand Pump/Dual HygieniKit 17153 Dual HygieniKit Sterile 17155 ECO SINGLE MILK COLLECTION SYSTEM 17105I ASY,SINGLE HYGIENIKIT,17111UKP One Hand Pump/Hygiene Kit 17150 ONE HAND HYGIENIKIT ADAPTER 17141 DUAL DISPOSABLE HYGIENIKIT 17115 DISPOSABLE HYGIENIKIT 17505T DISPOSABLE HYGIENIKIT 17105 One Hand Dual Pump - 17449 One Hand Single Pump 17448 One Hand Dual Pump - 17187 DUAL HIGIRNIKIT WITH 80ML

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)