BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    INFINITY MCABLE-NELLCOR OXIMAX

    DI: 04049098049665 · Model: MS20668 · DRAEGER MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    INFINITY MCABLE-NELLCOR OXIMAX
    Primary DI
    04049098049665
    Version / Model
    MS20668
    Company Name
    DRAEGER MEDICAL SYSTEMS, INC.
    Labeler DUNS
    788289952
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-10-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    8a2198dc-c065-4bb2-bf1e-57da45414259

    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
    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
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    GMDN Terms

    Code Name
    36554 Patient monitoring system module, pulse oximetry

    Identifiers

    Type ID
    Primary 04049098049665

    Customer Contacts

    Phone
    +18004372437
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K113798 000