BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Microlife

    DI: 00642632950249 · Model: OXY550 BT · MICROLIFE USA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Microlife
    Primary DI
    00642632950249
    Version / Model
    OXY550 BT
    Company Name
    MICROLIFE USA, INC.
    Labeler DUNS
    176387785
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-21
    Public Version
    2
    Public Version Date
    2024-10-28
    Public Version Status
    Update
    Public Device Record Key
    71fabd6a-6127-40b8-bef5-41585adb3ffa

    Device Description

    The Fingertip Pulse Oximeter is a non-invasive device intended for spotchecking of functional oxygen saturation of arterial hemoglobin (Spo2) and pulse rate.

    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
    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
    DQA Oximeter

    GMDN Terms

    Code Name
    45607 Pulse oximeter

    Identifiers

    Type ID
    Package 10642632950246
    Primary 00642632950249