BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PressureGuard®

    DI: H9338400X · Model: Custom Care Convertible · SPAN-AMERICA MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PressureGuard®
    Primary DI
    H9338400X
    Version / Model
    Custom Care Convertible
    Catalog Number
    8400X
    Company Name
    SPAN-AMERICA MEDICAL SYSTEMS, INC.
    Labeler DUNS
    073704413
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-02-11
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    b41de6dd-28b8-44f8-896b-0a26bde86fc9

    Device Description

    Alternating Pressure Mattress Control Unit

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FNM Mattress, Air Flotation, Alternating Pressure

    GMDN Terms

    Code Name
    47478 Alternating-pressure bed mattress overlay system

    Identifiers

    Type ID
    Primary H9338400X