BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ARC InstaTemp Infrared Thermometer

    DI: 00853524006009 · Model: 600 · ARC DEVICES USA INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ARC InstaTemp Infrared Thermometer
    Primary DI
    00853524006009
    Version / Model
    600
    Company Name
    ARC DEVICES USA INC
    Labeler DUNS
    079758824
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-03-27
    Public Version
    3
    Public Version Date
    2020-12-04
    Public Version Status
    Update
    Public Device Record Key
    8e874108-05a6-450a-a047-f82deae26cbc

    Device Description

    InstaTemp Digital Non-Touch Infrared Thermometer is intended to be used to measure temperature in infants and adults. The InstaTemp can be used in the home or in the clinical setting.

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    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
    Primary 00853524006009