BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    B-CAPTA

    DI: 08033178113113 · Model: 1/2" VENOUS CUVETTE · SORIN GROUP ITALIA SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    B-CAPTA
    Primary DI
    08033178113113
    Version / Model
    1/2" VENOUS CUVETTE
    Company Name
    SORIN GROUP ITALIA SRL
    Labeler DUNS
    442126587
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-05-05
    Public Version
    1
    Public Version Date
    2021-05-13
    Public Version Status
    New
    Public Device Record Key
    bf0720e2-2bc7-4650-827e-891d793b986b

    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DRY MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS

    GMDN Terms

    Code Name
    31715 Cardiopulmonary bypass system blood gas sensor

    Identifiers

    Type ID
    Package 38033178113114
    Primary 08033178113113

    Premarket Submissions

    Submission Number Supplement Number
    K202154 000