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    FDA UDI In Commercial Distribution 🇺🇸 United States

    True-Comfort Safety Pen Needles 4MM 32G

    DI: 00850058864006 · Model: 1 · HOME AIDE DIAGNOSTICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    True-Comfort Safety Pen Needles 4MM 32G
    Primary DI
    00850058864006
    Version / Model
    1
    Company Name
    HOME AIDE DIAGNOSTICS, INC.
    Labeler DUNS
    783518983
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-10-08
    Public Version
    1
    Public Version Date
    2024-10-16
    Public Version Status
    New
    Public Device Record Key
    754b92d8-da26-455a-814b-ca4675e716dd

    Device Description

    Safety Pen Needles 4MM 32G

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FMI Needle, Hypodermic, Single Lumen

    GMDN Terms

    Code Name
    17180 Subcutaneous infusion/injection port needle

    Identifiers

    Type ID
    Primary 00850058864006

    Customer Contacts

    Phone
    1-800-915-0116
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K192677 000

    Device Sizes

    Type Value Unit Text
    Needle Gauge 32 Gauge
    Length 4 Millimeter

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    0 – 40 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    40 – 60 Percent (%) Relative Humidity