BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Hang&Go PAC

    DI: M640R99001170001 · Model: 000 · RAND SPA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Hang&Go PAC
    Primary DI
    M640R99001170001
    Version / Model
    000
    Catalog Number
    R9900117
    Company Name
    RAND SPA
    Labeler DUNS
    655010531
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-02-21
    Public Version
    5
    Public Version Date
    2020-07-24
    Public Version Status
    Update
    Public Device Record Key
    0b5173ef-ae3f-495c-9164-599047f61403
    Distribution End Date
    2020-07-23

    Device Description

    Kit for hyperthermic perfusion

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LGZ Warmer, Thermal, Infusion Fluid

    GMDN Terms

    Code Name
    47761 Intravascular/intracavitary-circulation hyperthermia system set

    Identifiers

    Type ID
    Primary M640R99001170001

    Premarket Submissions

    Submission Number Supplement Number
    K161613 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    5 – 35 Degrees Celsius