BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DISP NLCR COMPAT SPO2 SNSR,NON OXMX,N25

    DI: 00840828180597 · Model: CSA001DN-E100 · CURBELL MEDICAL PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DISP NLCR COMPAT SPO2 SNSR,NON OXMX,N25
    Primary DI
    00840828180597
    Version / Model
    CSA001DN-E100
    Catalog Number
    26238
    Company Name
    CURBELL MEDICAL PRODUCTS, INC.
    Labeler DUNS
    796452311
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-04
    Public Version
    3
    Public Version Date
    2023-07-31
    Public Version Status
    Update
    Public Device Record Key
    0ce8d1bc-1a5e-448b-a58e-fa450e67ed4f

    Device Description

    DISP NLCR COMPAT SPO2 SNSR,NON OXMX,N25

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DSA Cable, Transducer And Electrode, Patient, (Including Connector)

    GMDN Terms

    Code Name
    31658 Pulse oximeter probe, single-use

    Identifiers

    Type ID
    Primary 00840828180597
    Package 10840828180594
    Package 00840828189422

    Customer Contacts

    Phone
    1-800-235-7500
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K182220 000