BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Emergency Rescue Mask

    DI: B859ERM1010 · Model: ERM101 · CBX LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Emergency Rescue Mask
    Primary DI
    B859ERM1010
    Version / Model
    ERM101
    Company Name
    CBX LLC
    Labeler DUNS
    110960383
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-02-15
    Public Version
    1
    Public Version Date
    2020-02-24
    Public Version Status
    New
    Public Device Record Key
    67b4cc64-3e03-4c5d-b864-5e7787fcc1d7

    Device Description

    It is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

    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
    Yes
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CBP Valve, Non-Rebreathing

    GMDN Terms

    Code Name
    61326 Cardiopulmonary resuscitation mask, single-use

    Identifiers

    Type ID
    Primary B859ERM1010