BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Iradimed

    DI: 00856038001683 · Model: 1171 · IRADIMED CORP.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Iradimed
    Primary DI
    00856038001683
    Version / Model
    1171
    Catalog Number
    1171
    Company Name
    IRADIMED CORP.
    Labeler DUNS
    170301969
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-11-17
    Public Version
    4
    Public Version Date
    2021-11-10
    Public Version Status
    Update
    Public Device Record Key
    6ab38488-a5cc-4b4a-b933-74b85f6d3654

    Device Description

    SpO2 Grip Sensor Starter Pack

    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 Conditional
    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
    MWI Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
    FRN Pump, Infusion

    GMDN Terms

    Code Name
    37808 Pulse oximeter probe, reusable

    Identifiers

    Type ID
    Primary 00856038001683

    Premarket Submissions

    Submission Number Supplement Number
    K090087 000
    K172200 000