BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BIOPHEN Protein C 2.5

    DI: 03663537008221 · Model: 221202 · HYPHEN BIOMED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    BIOPHEN Protein C 2.5
    Primary DI
    03663537008221
    Version / Model
    221202
    Catalog Number
    221202
    Company Name
    HYPHEN BIOMED
    Labeler DUNS
    503499167
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-25
    Public Version
    4
    Public Version Date
    2024-10-15
    Public Version Status
    Update
    Public Device Record Key
    cb12d920-f5ee-4bdf-bc99-f007cd5866f1
    Distribution End Date
    2017-09-30

    Device Characteristics

    Single Use
    Yes
    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
    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
    GGP Test, Qualitative And Quantitative Factor Deficiency

    GMDN Terms

    Code Name
    47388 Protein C IVD, kit, chromogenic

    Identifiers

    Type ID
    Primary 03663537008221

    Premarket Submissions

    Submission Number Supplement Number
    K050365 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius