BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Soma Safe Enclosure

    DI: 00861402000421 · Model: SSE 300e · VIVAX MEDICAL CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Soma Safe Enclosure
    Primary DI
    00861402000421
    Version / Model
    SSE 300e
    Company Name
    VIVAX MEDICAL CORPORATION
    Labeler DUNS
    154815062
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-11
    Public Version
    1
    Public Version Date
    2020-03-19
    Public Version Status
    New
    Public Device Record Key
    e71e1d65-bdde-4a0b-a471-d21eb58ac65a

    Device Description

    AC powered hospital bed with affixed frame for structural support of a canopy to prevent patient from exiting bed unassisted

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    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
    34870 Basic electric hospital bed

    Identifiers

    Type ID
    Primary 00861402000421

    Customer Contacts

    Phone
    +1(203)729-0514
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Length 93 Inch
    Height 72 Inch
    Width 39 Inch