BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CARELight

    DI: 00858935006457 · Model: CL-64R · HEALTHLIGHT LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CARELight
    Primary DI
    00858935006457
    Version / Model
    CL-64R
    Catalog Number
    602018
    Company Name
    HEALTHLIGHT LLC
    Labeler DUNS
    080183509
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-12-30
    Public Version
    1
    Public Version Date
    2020-01-07
    Public Version Status
    New
    Public Device Record Key
    939c0425-8a73-4813-8311-c67c02e067cb

    Device Description

    64-LED Red/IR CAREPad - Infrared Phototherapy Device

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    ILY Lamp, Infrared, Therapeutic Heating

    GMDN Terms

    Code Name
    35147 Musculoskeletal infrared phototherapy unit, non-wearable

    Identifiers

    Type ID
    Primary 00858935006457