BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FLTR

    DI: 00840061482823 · Model: PC828 · Shenzhen Pacom Medical Instruments Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FLTR
    Primary DI
    00840061482823
    Version / Model
    PC828
    Company Name
    Shenzhen Pacom Medical Instruments Co., Ltd.
    Labeler DUNS
    421356348
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-17
    Public Version
    2
    Public Version Date
    2020-12-04
    Public Version Status
    Update
    Public Device Record Key
    78e17f6b-d17b-498f-a127-935909e9902a

    Device Description

    Model: PC828; Brand: FLTR; One inner packing tray contains 6 devices; One outer packing box contains 36 inner packing trays.

    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
    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 00840061482823
    Package 10840061482820
    Package 20840061482827

    Premarket Submissions

    Submission Number Supplement Number
    K172889 000