BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT AU-425

    DI: 00817302020809 · Model: AU-425 · CAROLINA LIQUID CHEMISTRIES CORPORATION
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT AU-425
    Primary DI
    00817302020809
    Version / Model
    AU-425
    Catalog Number
    AU-425
    Company Name
    CAROLINA LIQUID CHEMISTRIES CORPORATION
    Labeler DUNS
    962385787
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-01
    Public Version
    3
    Public Version Date
    2025-03-13
    Public Version Status
    Update
    Public Device Record Key
    2995320c-5a96-4a38-9d12-68bce7cebd45

    Device Description

    6-AM (6-Acetylmorphine)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    Yes
    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
    DIF DRUG MIXTURE CONTROL MATERIALS
    DKB CALIBRATORS, DRUG MIXTURE
    DJG ENZYME IMMUNOASSAY, OPIATES

    GMDN Terms

    Code Name
    61891 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00817302020809

    Customer Contacts

    Phone
    +1(800)471-7272
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Total Volume 60 Milliliter
    Device Size Text, specify Kit contains 2 R1 and 2 R2 bottles and 1 package insert
    Total Volume 23 Milliliter

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    Kit can be expected to perform satisfactorily until the expiration date if stored in the refrigerator at 2-8°C.