BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    MiniOX

    DI: 08688250002566 · Model: MINIOX 1AS · OHIO MEDICAL, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MiniOX
    Primary DI
    08688250002566
    Version / Model
    MINIOX 1AS
    Company Name
    OHIO MEDICAL, LLC
    Labeler DUNS
    005192885
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-11-30
    Public Version
    5
    Public Version Date
    2020-04-30
    Public Version Status
    Update
    Public Device Record Key
    cb94dfa2-10c8-4c23-a28b-1338e106ccaf
    Distribution End Date
    2020-04-30

    Device Description

    Oxygen Analyzer with Sensor

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    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
    CCL Analyzer, Gas, Oxygen, Gaseous-Phase

    GMDN Terms

    Code Name
    46049 Respiratory oxygen monitor, battery-powered

    Identifiers

    Type ID
    Primary 08688250002566

    Customer Contacts

    Phone
    18478550500
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K961644 000