BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Actalyke XL, Dual Detection, (Display #2) "CE" (110V/220V)

    DI: M52557700020 · Model: 5770002 · HELENA LABORATORIES CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Actalyke XL, Dual Detection, (Display #2) "CE" (110V/220V)
    Primary DI
    M52557700020
    Version / Model
    5770002
    Company Name
    HELENA LABORATORIES CORPORATION
    Labeler DUNS
    836287433
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-22
    Public Version
    4
    Public Version Date
    2023-09-11
    Public Version Status
    Update
    Public Device Record Key
    4070a5df-a162-477f-964a-06110c03fb84

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JBP ACTIVATED WHOLE BLOOD CLOTTING TIME

    GMDN Terms

    Code Name
    56689 Coagulation analyser IVD, laboratory

    Identifiers

    Type ID
    Primary M52557700020

    Customer Contacts

    Phone
    +1(800)231-5663 ext. 1600
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K020914 000