BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RetroGuard Arterial Safety Valve

    DI: 10634624472003 · Model: 4007200 · QUEST MEDICAL INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    10

    Basic Information

    Brand Name
    RetroGuard Arterial Safety Valve
    Primary DI
    10634624472003
    Version / Model
    4007200
    Catalog Number
    4007200
    Company Name
    QUEST MEDICAL INC
    Labeler DUNS
    041810693
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2016-06-06
    Public Version
    3
    Public Version Date
    2019-11-13
    Public Version Status
    Update
    Public Device Record Key
    495b6a89-8545-41ec-9059-1df1a72cf553

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    MJJ Cpb Check Valve, Retrograde Flow, In-Line

    GMDN Terms

    Code Name
    17581 Cardiopulmonary bypass system valve, unidirectional flow/pressure control

    Identifiers

    Type ID
    Package 20634624472000
    Primary 10634624472003
    Unit of Use 00634624472006