BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Kelvi

    DI: 00850001185028 · Model: KLV20001 · HYPOTHERMIA DEVICES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Kelvi
    Primary DI
    00850001185028
    Version / Model
    KLV20001
    Company Name
    HYPOTHERMIA DEVICES, INC.
    Labeler DUNS
    079330735
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-17
    Public Version
    2
    Public Version Date
    2023-12-18
    Public Version Status
    Update
    Public Device Record Key
    134a9e14-c1f6-414c-9871-6379dab2f030

    Device Description

    Kelvi Shoulder Pro Smart Wrap

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ILO Pack, Hot Or Cold, Water Circulating

    GMDN Terms

    Code Name
    62442 Circulating-fluid localized thermal therapy system

    Identifiers

    Type ID
    Primary 00850001185028

    Customer Contacts

    Phone
    3104925886
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    1 – 52 Degrees Celsius