BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pure Comfort Tempa Check

    DI: 00850632007546 · Model: DET-215 · HOME AIDE DIAGNOSTICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Pure Comfort Tempa Check
    Primary DI
    00850632007546
    Version / Model
    DET-215
    Company Name
    HOME AIDE DIAGNOSTICS, INC.
    Labeler DUNS
    783518983
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-06
    Public Version
    2
    Public Version Date
    2020-12-04
    Public Version Status
    Update
    Public Device Record Key
    afb0b3c0-029f-4e85-b795-0345a41e783d

    Device Description

    Multi function infrared thermometer

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FLL Thermometer, Electronic, Clinical

    GMDN Terms

    Code Name
    17888 Infrared patient thermometer, skin

    Identifiers

    Type ID
    Package 10850632007543
    Primary 00850632007546
    Package 20850632007540

    Customer Contacts

    Phone
    1-800-915-0116
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -25 – 55 Degrees Celsius