BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BluPRO®

    DI: 04931921877432 · Model: TL-631T1 · NIHON KOHDEN CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BluPRO®
    Primary DI
    04931921877432
    Version / Model
    TL-631T1
    Catalog Number
    TL-631T1
    Company Name
    NIHON KOHDEN CORPORATION
    Labeler DUNS
    690568050
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-04-19
    Public Version
    4
    Public Version Date
    2023-10-09
    Public Version Status
    Update
    Public Device Record Key
    994be8fa-bc47-48f3-bcf7-e6e4991d65cd

    Device Description

    Finger probe Adult, child (20 kg or more) Finger or toe

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    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
    MHX MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
    DRG TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

    GMDN Terms

    Code Name
    37808 Pulse oximeter probe, reusable

    Identifiers

    Type ID
    Primary 04931921877432

    Customer Contacts

    Phone
    +1(800)325-0283
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K153707 000