BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Hyperinflation AMBU

    DI: 05707480137602 · Model: 900 000 618 · WESTMED, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Hyperinflation AMBU
    Primary DI
    05707480137602
    Version / Model
    900 000 618
    Company Name
    WESTMED, INC.
    Labeler DUNS
    092673953
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-08-07
    Public Version
    4
    Public Version Date
    2022-10-24
    Public Version Status
    Update
    Public Device Record Key
    cd9a1c84-cce9-4e8d-ba5d-0122f8649696

    Device Description

    Disposable Hyperinflation System, 7' O2 and Manometer, 40 CM POP off Valve, Infant Mask

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    BZR Mixer, Breathing Gases, Anesthesia Inhalation

    GMDN Terms

    Code Name
    37706 Ventilator breathing circuit, single-use

    Identifiers

    Type ID
    Package 05707480137619
    Primary 05707480137602

    Premarket Submissions

    Submission Number Supplement Number
    K932709 000