BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    HemoTemp II Activator

    DI: M74490000 · Model: 9000 · BIOSYNERGY, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    HemoTemp II Activator
    Primary DI
    M74490000
    Version / Model
    9000
    Company Name
    BIOSYNERGY, INC.
    Labeler DUNS
    070698154
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-06-01
    Public Version
    6
    Public Version Date
    2023-05-04
    Public Version Status
    Update
    Public Device Record Key
    f01275e6-f513-44a6-9505-a306ab7b0a51
    Distribution End Date
    2022-02-12

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    PM Exempt
    Yes
    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
    JRG Block, Heating

    GMDN Terms

    Code Name
    15105 Heating block IVD

    Identifiers

    Type ID
    Package M74490001
    Primary M74490000