BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vital Signs Patient Monitor

    DI: 00616784084015 · Model: 10840 · DYNAREX CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Vital Signs Patient Monitor
    Primary DI
    00616784084015
    Version / Model
    10840
    Company Name
    DYNAREX CORPORATION
    Labeler DUNS
    008124539
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-02-01
    Public Version
    1
    Public Version Date
    2020-02-10
    Public Version Status
    New
    Public Device Record Key
    3433be96-8fb5-48db-add7-f694420a19e5

    Device Description

    Vital Signs Patient Monitor - V6 w/ BLT sp02, BP, Temp

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

    GMDN Terms

    Code Name
    36553 Patient monitoring system module, multifunction

    Identifiers

    Type ID
    Primary 00616784084015

    Premarket Submissions

    Submission Number Supplement Number
    K153135 000