BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    C-Chip

    DI: 08809317540597 · Model: DHC-F01 · NanoEnTek, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    C-Chip
    Primary DI
    08809317540597
    Version / Model
    DHC-F01
    Catalog Number
    DHC-F01
    Company Name
    NanoEnTek, Inc.
    Labeler DUNS
    687910463
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-10-01
    Public Version
    2
    Public Version Date
    2020-11-04
    Public Version Status
    Update
    Public Device Record Key
    32558bbd-97a0-42b6-bd87-4d4b33e6f2b8

    Device Description

    The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leukocyte) counting. It consists of surface-patterned two enclosed chambers with two ports for sample injection. The DHC-F01 grid pattern is exactly the same as the Fuchs-Rosenthal. It consists of 16 large squares orientated by triple lines, each measuring 1 x 1 mm, giving a total area 4 x 4 mm.

    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
    Yes
    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
    GHO Hemocytometer

    GMDN Terms

    Code Name
    55854 Full blood count IVD, kit, cell count

    Identifiers

    Type ID
    Primary 08809317540597