BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rad-57™ Pulse CO-Oximeter™

    DI: 00843997012157 · Model: 3736 · MASIMO CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Rad-57™ Pulse CO-Oximeter™
    Primary DI
    00843997012157
    Version / Model
    3736
    Company Name
    MASIMO CORPORATION
    Labeler DUNS
    780421038
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    4
    Public Version Date
    2018-11-30
    Public Version Status
    Update
    Public Device Record Key
    e590a2b6-c06e-4cac-a2eb-5716c3642070

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    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
    46201 Pulse Co-oximeter

    Identifiers

    Type ID
    Primary 00843997012157
    Direct Marking 00843997013758

    Customer Contacts

    Phone
    +1(949)297-7498
    Email
    [email protected]