BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    K-6oem AIRE-TURN ASSIST

    DI: 00817012022360 · Model: U-K-6oemFAMSB48 · KAP MEDICAL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    K-6oem AIRE-TURN ASSIST
    Primary DI
    00817012022360
    Version / Model
    U-K-6oemFAMSB48
    Catalog Number
    U-K-6oemFAMSB48
    Company Name
    KAP MEDICAL
    Labeler DUNS
    135241342
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-05-15
    Public Version
    1
    Public Version Date
    2019-05-23
    Public Version Status
    New
    Public Device Record Key
    a2a988cf-95e0-457b-b30c-370f4dbaed13

    Device Description

    Alternating Pressure Turn Assist with On-Demand Low Air Loss Foam Air Mattress System

    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
    IKZ Bed, Patient Rotation, Powered

    GMDN Terms

    Code Name
    17593 Low-air-loss bed

    Identifiers

    Type ID
    Primary 00817012022360