BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BD MiniDraw Finger Sizing Tool

    DI: 00850058457055 · Model: 366617-100 · Babson Diagnostics, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    100

    Basic Information

    Brand Name
    BD MiniDraw Finger Sizing Tool
    Primary DI
    00850058457055
    Version / Model
    366617-100
    Catalog Number
    366617-100
    Company Name
    Babson Diagnostics, Inc.
    Labeler DUNS
    059454260
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2025-12-09
    Public Version
    1
    Public Version Date
    2025-12-17
    Public Version Status
    New
    Public Device Record Key
    e2fbd7d1-77f3-465b-b33f-fb6c41fb58d2

    Device Description

    BD MiniDraw Finger Sizing Tool

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GIM Tubes, Vacuum Sample, With Anticoagulant
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

    GMDN Terms

    Code Name
    67129 Capillary blood collection finger diameter sizer IVD

    Identifiers

    Type ID
    Unit of Use 00382903666171
    Primary 00850058457055

    Premarket Submissions

    Submission Number Supplement Number
    K230391 000
    K230493 000