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    FDA Registration Active 🇺🇸 United States

    PFMMedical6614 (TM) - ASEPT Drainage Line Set (Ref 622286)

    Reg #: 2030624 · FEI: 3000206435 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Isomedix Operations, Inc.
    Registration Number
    2030624
    FEI Number
    3000206435
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    43425 Business Park Dr
    City
    Temecula
    State
    CA
    ZIP
    92590
    Country
    US

    Regulatory Submissions

    510(k) Number
    K093307

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    1527821
    Address
    5960 Heisley Rd, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Apparatus, Suction, Patient Care DWM

    Proprietary Names

    PFMMedical6614 (TM) - ASEPT Drainage Line Set (Ref 622286) PFMMedical6614 (TM) - ASEPT Pleural Catheter Kit (Ref 622289) PFMMedical6614 (TM) - ASEPT Replacement Valve (Ref 622288) PFMMedical6614 (TM) - ASEPT Pleural Drainage System (Ref M7001)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)