BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Slovene, Rapid Infuser, 230 V, 750ml/min

    DI: 00896128002336 · Model: 903-00001A-SL · BELMONT INSTRUMENT CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Slovene, Rapid Infuser, 230 V, 750ml/min
    Primary DI
    00896128002336
    Version / Model
    903-00001A-SL
    Company Name
    BELMONT INSTRUMENT CORPORATION
    Labeler DUNS
    078330362
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    b39e8458-17fe-4c60-b597-6b2f57de4994

    Device Description

    Fluid Warmer, 230V UNIT, 750ml/min

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FRN Pump, Infusion
    LGZ Warmer, Thermal, Infusion Fluid

    GMDN Terms

    Code Name
    17907 Warming/high-flow infusion pump

    Identifiers

    Type ID
    Primary 00896128002336

    Premarket Submissions

    Submission Number Supplement Number
    K091855 000