BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HAEMONETICS SMARTSUCTION HARMONY SYSTEM

    DI: 10812747017343 · Model: HAR-A-1001 · HAEMONETICS CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HAEMONETICS SMARTSUCTION HARMONY SYSTEM
    Primary DI
    10812747017343
    Version / Model
    HAR-A-1001
    Company Name
    HAEMONETICS CORPORATION
    Labeler DUNS
    057827420
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-09-24
    Public Version
    5
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    15032163-c571-49dc-82a1-a10fe3c91a7a

    Device Description

    VACUUM LINE, UNFILTERED

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    BTA Pump, Portable, Aspiration (Manual Or Powered)

    GMDN Terms

    Code Name
    17605 Autotransfusion system blood component processing set

    Identifiers

    Type ID
    Package 30812747017347
    Primary 10812747017343

    Customer Contacts

    Phone
    800-537-2802
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K052626 000