BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    OXY-1 System

    DI: 10860001797968 · Model: Console Intake Filter, 5pk · Breethe, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    5

    Basic Information

    Brand Name
    OXY-1 System
    Primary DI
    10860001797968
    Version / Model
    Console Intake Filter, 5pk
    Catalog Number
    001-3300-039
    Company Name
    Breethe, Inc.
    Labeler DUNS
    079455574
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    5
    Record Status
    Published
    Publish Date
    2020-12-02
    Public Version
    2
    Public Version Date
    2023-05-19
    Public Version Status
    Update
    Public Device Record Key
    1f11066a-8e43-450f-a753-4d7aa1b042b8
    Distribution End Date
    2022-12-14

    Device Description

    Console Intake Filter, 5pk

    Device Characteristics

    Single Use
    No
    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
    No

    Product Codes

    Code Name
    DWA Control, Pump Speed, Cardiopulmonary Bypass

    GMDN Terms

    Code Name
    46838 Cardiopulmonary bypass system, non-roller type

    Identifiers

    Type ID
    Unit of Use 00860001797961
    Primary 10860001797968