BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NMIC-315

    DI: 30382904490851 · Model: 449085 · BECTON, DICKINSON AND COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    25

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    Basic Information

    Brand Name
    NMIC-315
    Primary DI
    30382904490851
    Version / Model
    449085
    Catalog Number
    449085
    Company Name
    BECTON, DICKINSON AND COMPANY
    Labeler DUNS
    122561087
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    25
    Record Status
    Published
    Publish Date
    2026-01-29
    Public Version
    1
    Public Version Date
    2026-02-06
    Public Version Status
    New
    Public Device Record Key
    692f86e6-9821-4a62-a475-4da3c59f10f3

    Device Description

    BD Phoenix™ NMIC-315

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LON SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

    GMDN Terms

    Code Name
    43554 Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent

    Identifiers

    Type ID
    Unit of Use 00382904490850
    Primary 30382904490851

    Customer Contacts

    Phone
    +1(800)638-8663
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K020322 000
    K023444 000
    K023634 000
    K023858 000
    K031699 000
    K031912 000
    K042932 000
    K060217 000
    K060257 000
    K060444 000
    K060447 000
    K061355 000
    K063301 000
    K063486 000
    K063573 000
    K063811 000
    K063824 000
    K071623 000
    K123404 000
    K132674 000
    K132909 000
    K151320 000
    K163637 000
    K173252 000
    K173523 000
    K233986 000
    K250447 000
    K251713 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 25 Degrees Celsius