BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Santamedical

    DI: 06945040104483 · Model: SM-165 · Contec Medical Systems Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Santamedical
    Primary DI
    06945040104483
    Version / Model
    SM-165
    Company Name
    Contec Medical Systems Co., Ltd.
    Labeler DUNS
    529606295
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-09-01
    Public Version
    3
    Public Version Date
    2021-11-10
    Public Version Status
    Update
    Public Device Record Key
    1f8cdfea-80ad-4b37-9c44-28b1d8ba0ac9

    Device Description

    Pulse Oximeter.Sports and aviation.OCH

    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
    Yes
    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
    OCH Oximeter, Infrared, Sporting, Aviation

    GMDN Terms

    Code Name
    45607 Pulse oximeter

    Identifiers

    Type ID
    Package 16945040104480
    Primary 06945040104483