BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    PNEUMOCLEAR HIGH-FLOW TUBE SET

    Reg #: 3008837339 · FEI: 3008837339 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    STRYKER EMEA Supply Chain Services
    Registration Number
    3008837339
    FEI Number
    3008837339
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Frans Maasweg 2
    City
    Venlo Limburg
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K170784

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    Products

    Device Name Product Code
    Insufflator, Laparoscopic HIF
    Insufflator, Endoscopic Vessel Harvesting OSV

    Proprietary Names

    PNEUMOCLEAR HIGH-FLOW TUBE SET PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (North America) PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (GLOBAL) PNEUMOCLEAR HEATED HUMIDIFIED SMOKE EVACUATION TUBE SET PNEUMOCLEAR CO2 CONDITIONING INSUFFLATOR (GLOBAL) PNEUMOCLEAR HEATED HUMIDIFIED TUBE SET PNEUMOCLEAR SMOKE EVACUATION HIGH-FLOW TUBE SET PNEUMOCLEAR HEATED HIGH-FLOW TUBE SET PNEUMOCLEAR CO2 CONDITIONING INSUFFLATOR (North America)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device