BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KLUGE DESIGN INC.

    Reg #: 3003661577 · FEI: 3003661577 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    21
    Establishment Types
    1
    Classifications
    10

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    Registration Details

    Registration Name
    KLUGE DESIGN INC.
    Registration Number
    3003661577
    FEI Number
    3003661577
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    14150 Northdale Blvd
    City
    Rogers
    State
    MN
    ZIP
    55374
    Country
    US

    Owner / Operator

    Firm Name
    Kluge Design LLC
    Operator Number
    10030771
    Address
    14150 Northdale Blvd
    City
    Rogers
    State
    MN
    Postal Code
    55374
    Country
    US
    Correspondent
    Erik Kariniemi

    Products

    Device Name Product Code
    Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type KFM
    Scalpel, One-Piece GDX
    Reservoir, Blood, Cardiopulmonary Bypass DTN
    Retractor GAD
    Catheter, Hemodialysis, Non-Implanted MPB
    Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use NQJ
    Accessory Equipment, Cardiopulmonary Bypass KRI
    Warmer, Peritoneal Dialysate MLW
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    Affinity CP Adapter Trigger Tome Release System HOLDER 1303 MINIMAX VRB ThoraTrak Model 28603, Blade Long Thoracotomy Standard 16L ThoraTrak Model 28606B, Blade Short Extended Mount Standard 16L ThoraTrak Model, 28604B, Blade Long Extended Mount Standard 16L ThoraTrak Model 28606, Blade Short Thoracotomy Deep 16L KIT THT-JPSTD THORATRAK JP Standard Set ThoraTrak Model 28602, Blade LIMA Deep 16L KIT THT-WWSTD THORATRAK Full System Set ThoraTrak Model 28605, Blade Short Thoracotomy Standard 16L ThoraTrak Model 28604, Blade Long Thoracotomy Deep 16L ThoraTrak Model 28611, Retractor Rack ThoraTrak Model 28601, Blade LIMA Standard 16L ThoraTrak Model 28610, Retractor System Dual Lumen Extended Length Catheter (dELC) VitalFlow Caddy HOLDER MVR-SH 1EA MVR HT2000 Aquadex MR Elastography System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)