BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HemoBand HB-NSXL

    Reg #: 3004202080 · FEI: 1000126788 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    INNOVATIONS FOR ACCESS, INC.
    Registration Number
    3004202080
    FEI Number
    1000126788
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8531 NE Cornell Rd, STE 800,
    City
    Hillsboro
    State
    OR
    ZIP
    97124
    Country
    US

    Regulatory Submissions

    510(k) Number
    K081740

    Owner / Operator

    Firm Name
    INNOVATIONS FOR ACCESS, INC.
    Operator Number
    9058740
    Address
    515 NW SALTZMAN ROAD #797, --
    City
    Portland
    State
    OR
    Postal Code
    97229
    Country
    US
    Correspondent
    HAL J OIEN, DMD, MAGD

    Products

    Device Name Product Code
    Accessories, Blood Circuit, Hemodialysis KOC

    Proprietary Names

    HemoBand HB-NSXL HemoBand HB-NS

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device