BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Tri-Kleen

    DI: 00866849000416 · Model: 400 · TRI-DIM FILTER CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tri-Kleen
    Primary DI
    00866849000416
    Version / Model
    400
    Company Name
    TRI-DIM FILTER CORPORATION
    Labeler DUNS
    191408400
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-09-05
    Public Version
    5
    Public Version Date
    2020-01-16
    Public Version Status
    Update
    Public Device Record Key
    9ed0d9ad-7bad-400f-b94b-7ecb214c40fe
    Distribution End Date
    2018-09-04

    Device Description

    Tri-Kleen Air Purification System, 115 Volt, 2.5 Amp, 60 Hz. Electrical Safety: CAN/CSA C22.2 No. 113:2015-05 & UL 507:1999/R2012-06. Mechanical safety: CAN/CSA C22.2 No. 113:2015-05 & UL 507:1999/R2012-06. Made in Canada

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    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
    FRF Cleaner, Air, Medical Recirculating

    GMDN Terms

    Code Name
    18113 High-efficiency filter air cleaner, mobile

    Identifiers

    Type ID
    Primary 00866849000416

    Premarket Submissions

    Submission Number Supplement Number
    K984116 000