BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Centesis Procedure Kit

    DI: 00886333221004 · Model: ATPK1005 · ARGON MEDICAL DEVICES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Centesis Procedure Kit
    Primary DI
    00886333221004
    Version / Model
    ATPK1005
    Catalog Number
    ATPK1005
    Company Name
    ARGON MEDICAL DEVICES, INC.
    Labeler DUNS
    140727624
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-07-20
    Public Version
    1
    Public Version Date
    2022-07-28
    Public Version Status
    New
    Public Device Record Key
    6eee049f-3829-495d-bba6-f63959a8c922

    Device Description

    Centesis Procedure Kit 5F x 10cm Skater™ Safety Centesis Catheter with Air Lock Valve

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    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
    OJT Aspiration Tray

    GMDN Terms

    Code Name
    36142 Aspiration tray, single-use

    Identifiers

    Type ID
    Package 20886333221008
    Primary 00886333221004

    Customer Contacts

    Phone
    1.800.927.4669
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 5F x 10cm