BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AMBU Hyperinflation System

    DI: 10889483542958 · Model: 900 000 611 · WESTMED, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AMBU Hyperinflation System
    Primary DI
    10889483542958
    Version / Model
    900 000 611
    Company Name
    WESTMED, INC.
    Labeler DUNS
    092673953
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-03-05
    Public Version
    2
    Public Version Date
    2026-04-20
    Public Version Status
    Update
    Public Device Record Key
    ad3cd014-1edb-4bbc-844c-5f868fef1a34

    Device Description

    Hyperinflation System, Manometer Dock, 7' O2 and Manometer

    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
    Yes
    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
    36086 Pulmonary resuscitator, manual, single-use

    Identifiers

    Type ID
    Package 20889483542962
    Primary 10889483542958