BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PVC Transfer Bag

    DI: 10816203023275 · Model: 10-200 · ORIGEN BIOMEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    2

    Basic Information

    Brand Name
    PVC Transfer Bag
    Primary DI
    10816203023275
    Version / Model
    10-200
    Company Name
    ORIGEN BIOMEDICAL, INC.
    Labeler DUNS
    625272232
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2017-06-06
    Public Version
    4
    Public Version Date
    2021-01-08
    Public Version Status
    Update
    Public Device Record Key
    9802efe5-ab71-4229-b125-bb16431de525

    Device Description

    One 200ml PVC processing bag, with a male luer, a female luer, a needle-free injection port and a spike port

    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
    KSR Container, Empty, For Collection & Processing Of Blood & Blood Components

    GMDN Terms

    Code Name
    16752 Blood washing/centrifugation bag

    Identifiers

    Type ID
    Package 20816203023272
    Primary 10816203023275
    Unit of Use 00816203023278

    Customer Contacts

    Phone
    512-474-7278
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    BK140116 0