BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    oneNEST S

    DI: 00670482000708 · Model: 303-803508HS4FB-BIL · Umano Medical Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    oneNEST S
    Primary DI
    00670482000708
    Version / Model
    303-803508HS4FB-BIL
    Catalog Number
    303-803508HS4FB-BIL
    Company Name
    Umano Medical Inc
    Labeler DUNS
    249675476
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-05-01
    Public Version
    2
    Public Version Date
    2024-05-15
    Public Version Status
    Update
    Public Device Record Key
    499e0520-8a91-4235-9b67-eedb3919c4b3

    Device Description

    oneNEST S 80''x 35'' is a non-powered foam surface

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IKY Mattress, Flotation Therapy, Non-Powered

    GMDN Terms

    Code Name
    63237 Foam bed mattress

    Identifiers

    Type ID
    Primary 00670482000708
    Package 10670482000705