BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HEPA-CARE®

    DI: 00818261022002 · Model: HC800FD · ABATEMENT TECHNOLOGIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HEPA-CARE®
    Primary DI
    00818261022002
    Version / Model
    HC800FD
    Company Name
    ABATEMENT TECHNOLOGIES, INC.
    Labeler DUNS
    173503806
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-15
    Public Version
    1
    Public Version Date
    2020-01-23
    Public Version Status
    New
    Public Device Record Key
    44688b36-ef44-479f-be10-9a29d46f0671

    Device Description

    HEPA-CARE® Digital Portable Unit, 120 Volt, 3.5 Amp, 60 Hz. Motor thermally protected, single phase. Electrical 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 00818261022002

    Customer Contacts

    Phone
    18006349091
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K984116 000