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    FDA UDI In Commercial Distribution 🇺🇸 United States

    RIKEN KEIKI Co.,Ltd.

    DI: 04571501890019 · Model: FI-8000 · RIKEN KEIKI CO.,LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RIKEN KEIKI Co.,Ltd.
    Primary DI
    04571501890019
    Version / Model
    FI-8000
    Catalog Number
    PC3E-0421
    Company Name
    RIKEN KEIKI CO.,LTD.
    Labeler DUNS
    690573670
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-03-26
    Public Version
    1
    Public Version Date
    2025-04-03
    Public Version Status
    New
    Public Device Record Key
    710ede80-bd74-49a8-82cf-569942689d3b

    Device Description

    ANALYZER,GAS,HALOTANE,GASEOUS-PHASE(ANESTHETICCONC.)

    Device Characteristics

    Single Use
    Yes
    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
    CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

    GMDN Terms

    Code Name
    36792 Anaesthesia vaporizer tester

    Identifiers

    Type ID
    Primary 04571501890019