BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BD Phoenix™ NMIC/ID-130

    DI: 30382904487301 · Model: 448730 · BECTON, DICKINSON AND COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    25

    Basic Information

    Brand Name
    BD Phoenix™ NMIC/ID-130
    Primary DI
    30382904487301
    Version / Model
    448730
    Catalog Number
    448730
    Company Name
    BECTON, DICKINSON AND COMPANY
    Labeler DUNS
    122561087
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    25
    Record Status
    Published
    Publish Date
    2016-08-09
    Public Version
    4
    Public Version Date
    2018-11-08
    Public Version Status
    Update
    Public Device Record Key
    71388a23-9551-4418-a6cf-9da883158361

    Device Description

    BD Phoenix™ NMIC/ID-130

    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
    Primary 30382904487301
    Unit of Use 00382904487300

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K020322 000
    K023444 000
    K023634 000
    K023858 000
    K031429 000
    K031530 000
    K031699 000
    K032153 000
    K032275 000
    K032299 000
    K032655 000
    K033362 000
    K033458 000
    K041384 000
    K042932 000
    K043389 000
    K052269 000
    K060217 000
    K060444 000
    K060447 000
    K061327 000
    K061355 000
    K062207 000
    K062944 000
    K063301 000
    K063573 000
    K063811 000
    K063824 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 25 Degrees Celsius