BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Spo2 Probe (Lumenair™ and Model TS4)

    DI: 00817980021327 · Model: Model Lumenair · VASOMEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Spo2 Probe (Lumenair™ and Model TS4)
    Primary DI
    00817980021327
    Version / Model
    Model Lumenair
    Catalog Number
    V83-0253
    Company Name
    VASOMEDICAL, INC.
    Labeler DUNS
    197210248
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-11-29
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    f3c672cf-2493-4d2e-87ef-e4008cbaa699

    Device Description

    Spo2 Probe (Lumenair™ and Model TS4)

    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
    No
    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
    DRN Device, counter-pulsating, external

    GMDN Terms

    Code Name
    17148 Pulse oximeter, line-powered

    Identifiers

    Type ID
    Primary 00817980021327

    Customer Contacts

    Phone
    +1(516)508-5818
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K033617 000