BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PFMMedical6614 (TM) - 3F x 45cm Single Lumen CT PICC (Ref: PFM2CT3S)

    Reg #: 2030624 · FEI: 3000206435 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    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
    K072391

    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
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS

    Proprietary Names

    PFMMedical6614 (TM) - 3F x 45cm Single Lumen CT PICC (Ref: PFM2CT3S) PFMMedical6614 (TM) - 4F x 50cm Dual Lumen CT PICC SV OTW Kit (Ref PFM2CT4DR) PFMMedical6614 (TM) - 3F x 45cm Single Lumen CT PICC Nursing Kit (Ref PFM2CT3SP) PFMMedical6614 (TM) - 3F x 45cm Single Lumen CT PICC SV OTW Kit (Ref PFM2CT3SR) PFMMedical6614 (TM) - 4F x 50cm Dual Lumen CT PICC Nursing Kit (Ref: PFM2CT4DN) PFMMedical6614 (TM) - 3F x 45cm Single Lumen CT PICC OTW Kit (Ref: PFM2CT3SL) PFMMedical6614 (TM) - 4F x 50cm Dual Lumen CT PICC Kit (Ref PFM2CT4DW) PFMMedical6614 (TM) - 3F x 45cm Single Lumen CT PICC Kit (Ref PFM2CT3SW) PFMMedical6614 (TM) - 4F x 50cm Dual Lumen CT PICC (Ref: PFM2CT4D) PFMMedical6614 (TM) - 4F x 50cm Dual Lumen CT PICC Nursing Kit (Ref PFM2CT4DP) PFMMedical6614 (TM) - 3F x 45cm Single Lumen CT PICC Nursing Kit (Ref: PFM2CT3SN)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)