BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MAHURKAR™ Elite Acute Dual Lumen High Flow Catheters, Kits, and Trays

    Reg #: 1319639 · FEI: 1000138054 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    87
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1319639
    FEI Number
    1000138054
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    84 Park Rd
    City
    Queensbury
    State
    NY
    ZIP
    12804
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120674

    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
    Catheter, Hemodialysis, Non-Implanted MPB
    Catheter, Hemodialysis, Triple Lumen, Non-Implanted NIE

    Proprietary Names

    MAHURKAR™ Elite Acute Dual Lumen High Flow Catheters, Kits, and Trays MAHURKAR™ Elite Acute Dual Lumen Catheters, Kits, and Tray MAHURKAR™ Elite Acute Triple Lumen Catheters, Kits, and Trays Mahurkar Elite 12 FR x 20cm Acute Dual Lumen Catheter with Curved Extensions, and 2 sealing caps MAHURKAR Elite Dual Lumen High Flow Catheter with Curved Cannula, 13.5 FR x 16 cm, Kit, Sterile Mahurkar Elite 12FR x 24cm Acute Dual Lumen Catheter with Straight Extensions, IC Tray MAHURKAR Elite Dual Lumen High Flow Catheter with Curved Cannula, 13.5 FR x 13 cm, Kit, Sterile MAHURKAR Elite Acute Dual Lumen Catheter with Curved Cannula, 12 FR x 13 cm, Single, Sterile Mahurkar Elite 12 FR x 13cm Acute Dual Lumen Catheter with Curved Extensions, Kit Mahurkar Elite 12FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, Kit Mahurkar Elite 13.5FR x 13cm Pre-Curved High Flow Acute Dual Lumen Catheter, and 2 Sealing Caps Mahurkar Elite 12FR x 16cm Pre-Curved Acute Dual Lumen Catheter, IC Tray Mahurkar Elite 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Straight Extensions, Kit Mahurkar Elite 12FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, and 2 Sealing Caps Mahurkar Elite 13.5FR x 16cm High Flow Acute Dual Lumen Catheter with Curved Extensions, and 2 sealing caps MAHURKAR Elite Acute Dual Lumen Catheter with Curved Cannula, 12 FR x 20 cm, PASS Tray, Sterile Mahurkar Elite 13.5FR x 30cm High Flow Dual Lumen Catheter with Straight Extensions, PASS Tray Mahurkar Elite 12FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, IC Tray Mahurkar Elite 13.5FR x 30cm High Flow Acute Dual Lumen Catheter with Straight Extensions, and 2 sealing caps MAHURKAR Elite Dual Lumen Catheter with Curved Extensions, 12 FR x 16 cm, Kit, Sterile Mahurkar Elite 12FR x 20cm Acute Dual Lumen Catheter with Straight Extensions, and 2 Sealing Caps Mahurkar Elite 13.5FR x 24cm High Flow Acute Dual Lumen Catheter with Curved Extensions, IC Tray Mahurkar Elite 12FR x 30cm Acute Dual Lumen Catheter with Straight Extensions, and 2 Sealing Caps Mahurkar Elite 13.5FR x 20cm High Flow Acute Dual Lumen Catheter with Curved Extensions, Kit Mahurkar Elite 13.5FR x 16cm High Flow Acute Dual Lumen Catheter with Straight Extensions, Kit Mahurkar Elite 12 FR x 24cm Acute Dual Lumen Catheter with Curved Extensions, IC Tray Mahurkar Elite 12 FR x 13cm Acute Dual Lumen Catheter with Curved Extensions, and 2 sealing caps Mahurkar Elite 12FR x 24cm Acute Dual Lumen Catheter with Straight Extensions, Kit Mahurkar Elite 13.5FR x 24cm High Flow Acute Dual Lumen Catheter with Straight Extensions, Kit Mahurkar Elite 13.5FR x 24cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray Mahurkar Elite 12 FR x 24cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray Mahurkar Elite 13.5FR x 20cm High Flow Acute Dual Lumen Catheter with Curved Extensions, IC Tray Mahurkar Elite 13.5FR x 24cm High Flow Acute Dual Lumen Catheter with Straight Extensions, IC Tray Mahurkar Elite 12FR x 16cm Pre-Curved Acute Dual Lumen Catheter, Kit Mahurkar Elite 12 FR x 20cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray Mahurkar Elite 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray Mahurkar Elite 12FR x 20cm Pre-Curved Acute Dual Lumen Catheter, Kit Mahurkar Elite 12 FR x 13cm Acute Dual Lumen Catheter with Curved Extensions, IC Tray Mahurkar Elite 12 FR x 24cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray Mahurkar Elite 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray Mahurkar Elite 12FR x 13cm Pre-Curved Acute Dual Lumen Catheter, IC Tray Mahurkar Elite 12FR x 16cm Acute Dual Lumen Catheter with Straight Extensions, and 2 Sealing Caps Mahurkar Elite 12 FR x 20cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray Mahurkar Elite 12 FR x 16cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray Mahurkar Elite 13.5FR x 24cm High Flow Acute Dual Lumen Catheter with Curved Extensions, Kit Mahurkar Elite 13.5FR x 20cm High Flow Acute Dual Lumen Catheter with Straight Extensions, and 2 sealing caps Mahurkar Elite 12 FR x 20cm Acute Dual Lumen Catheter with Curved Extensions, IC Tray Mahurkar Elite 13.5FR x 16cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray Mahurkar Elite 13.5FR x 24cm High Flow Acute Dual Lumen Catheter with Straight Extensions, and 2 sealing caps MAHURKAR Elite Acute Dual Lumen High Flow Catheter with Curved Cannula, 13.5 FR x 13 cm, PASS Tray, Sterile Mahurkar Elite 12FR x 30cm Acute Dual Lumen Catheter with Straight Extensions, IC Tray Mahurkar Elite 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Curved Extensions, and 2 sealing caps Mahurkar Elite 12FR x 30cm Acute Dual Lumen Catheter with Straight Extensions, Kit Mahurkar Elite 12FR x 20cm Acute Dual Lumen Catheter with Straight Extensions, IC Tray MAHURKAR Elite Acute Dual Lumen Catheter with Curved Cannula, 12 FR x 16 cm, PASS Tray, Sterile Mahurkar Elite 13.5 FR x 24 cm, High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray Mahurkar Elite 12 FR x 13cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray MAHURKAR Elite Acute Dual Lumen Catheter with Curved Cannula, 12 FR x 13 cm, PASS Tray, Sterile Mahurkar Elite 12FR x 13cm Pre-Curved Acute Dual Lumen Catheter, Kit Mahurkar Elite 13.5FR x 16cm High Flow Acute Dual Lumen Catheter with Curved Extensions, IC Tray MAHURKAR Elite Dual Lumen Catheter with Curved Extensions, 12 FR x 20 cm, Kit, Sterile MAHURKAR Elite Acute Dual Lumen High Flow Catheter with Curved Cannula, 13.5 FR x 20 cm, PASS Tray, Sterile Mahurkar Elite 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray Mahurkar Elite 13.5FR x 16cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray Mahurkar Elite 12FR x 16cm Acute Dual Lumen Catheter with Straight Extensions, Kit Mahurkar Elite 13.5FR x 30cm High Flow Acute Dual Lumen Catheter with Straight Extensions, IC Tray Mahurkar Elite 13.5FR x 20cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray Mahurkar Elite 12FR x 16cm Acute Dual Lumen Catheter with Straight Extensions, IC Tray Mahurkar Elite 13.5FR x 16cm High Flow Acute Dual Lumen Catheter with Curved Extensions, Kit Mahurkar Elite 13.5FR x 20cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray Mahurkar Elite 13.5FR x 20cm High Flow Acute Dual Lumen Catheter with Straight Extensions, IC Tray Mahurkar Elite 12 FR x 30cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray Mahurkar Elite 13.5FR x 13cm Pre-Curved High Flow Acute Dual Lumen Catheter, IC Tray Mahurkar Elite 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Curved Extensions, IC Tray Mahurkar Elite 13.5FR x 20cm High Flow Acute Dual Lumen Catheter with Straight Extensions, Kit Mahurkar Elite 12FR x 20cm Acute Dual Lumen Catheter with Straight Extensions, Kit MAHURKAR Elite Acute Dual Lumen High Flow Catheter with Curved Cannula, 13.5 FR x 16 cm, PASS Tray, Sterile MAHURKAR Elite Dual Lumen Catheter with Curved Extensions, 12 FR x 24 cm, Kit, Sterile MAHURKAR Elite Dual Lumen High Flow Catheter with Curved Cannula, 13.5 FR x 20 cm, Kit, Sterile Mahurkar Elite 13.5FR x 16cm Pre-Curved High Flow Acute Dual Lumen Catheter, IC Tray Mahurkar Elite 13.5FR x 30cm High Flow Acute Dual Lumen Catheter with Straight Extensions, Kit Mahurkar Elite 13.5FR x 20cm Pre-Curved High Flow Acute Dual Lumen Catheter, IC Tray Mahurkar Elite 12 FR x 16cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray Mahurkar Elite 13.5FR x 16cm High Flow Acute Dual Lumen Catheter with Straight Extensions, IC Tray Mahurkar Elite 12 FR x 16cm Acute Dual Lumen Catheter with Curved Extensions, IC Tray Mahurkar Elite 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Curved Extensions, Kit Mahurkar Elite 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Straight Extensions, IC Tray

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)