BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Perfusor Space

    Reg #: 9610825 · FEI: 3002806469 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    B. BRAUN MELSUNGEN AG
    Registration Number
    9610825
    FEI Number
    3002806469
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    CARL-BRAUN-STR.1
    City
    MELSUNGEN Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K092313

    Owner / Operator

    Firm Name
    B. BRAUN MELSUNGEN AG
    Operator Number
    8010484
    Address
    CARL-BRAUN-STR.1, --
    City
    MELSUNGEN
    State
    DE-NOTA
    Postal Code
    34212
    Country
    DE
    Correspondent
    Kamaal Anas

    US Agent

    Business Name
    B. BRAUN MEDICAL, INC.
    Contact Name
    Kamaal Anas
    Address
    824 Twelfth Avenue
    City
    Bethlehem
    State
    PA
    ZIP
    18018
    Country
    US
    Email
    [email protected]
    Phone
    484 5231349

    Products

    Device Name Product Code
    Pump, Infusion, Pca MEA
    Pump, Infusion FRN

    Proprietary Names

    Perfusor Space Perfusor Space ACM Perfusor Space PCA

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility