BEUDAMED
    FDA Registration Active 🇺🇸 United States

    K782095 Oxygenator, Cardiopulmonary Bypass"NAMIC¿ Angiographic Manifold

    Reg #: 1319639 · FEI: 1000138054 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    1

    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
    K782095

    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
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL

    Proprietary Names

    K782095 Oxygenator, Cardiopulmonary Bypass"NAMIC¿ Angiographic Manifold AFFINITY® NT Hollow Fiber Oxygenator Affinity NT Integrated CVB Oxygenator Pediatric Arterial Blood Filter AFFINITY® NT Hollow Fiber Oxygenator MINIMAX PLUS® Hollow Fiber Oxygenator Blood Tubing Pack INTERSEPT® Cardiotomy Reservoir NAMIC Angiographic Manifold NAMIC Stopcocks NAMIC Standard Angiographic Kit NAMIC Angiographic Pressure Monitoring Manifold NAMIC Standard Peripheral Vascular Angiographic Kit NAMIC MLL-RA Adaptor NAMIC Manifold Clamp

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)