BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DANLEE MEDICAL KIT

    DI: 00816310020009 · Model: CAR470007501 · DANLEE MEDICAL PRODUCTS, INC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    DANLEE MEDICAL KIT
    Primary DI
    00816310020009
    Version / Model
    CAR470007501
    Company Name
    DANLEE MEDICAL PRODUCTS, INC
    Labeler DUNS
    878130871
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-05-17
    Public Version
    4
    Public Version Date
    2021-02-19
    Public Version Status
    Update
    Public Device Record Key
    4e4bb2c7-5b79-40eb-b55b-e7b3d31fb03d

    Device Description

    MICROSAFE TUBE KIT (ZKIT) CONMED

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    35770 Capillary blood collection tube IVD, no additive

    Identifiers

    Type ID
    Primary 00816310020009