BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Boekel Floor Standing Platelet Incubator Agitator

    DI: 00863626000294 · Model: FS100 · BOEKEL INDUSTRIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Boekel Floor Standing Platelet Incubator Agitator
    Primary DI
    00863626000294
    Version / Model
    FS100
    Catalog Number
    FS100
    Company Name
    BOEKEL INDUSTRIES, INC.
    Labeler DUNS
    002288215
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-08
    Public Version
    1
    Public Version Date
    2023-06-16
    Public Version Status
    New
    Public Device Record Key
    47656414-9e06-45b9-a315-e4c84e0ca46d

    Device Description

    Chamber that maintains 22 degrees C with constant agitation motion for the storage of Platelets.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    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

    Product Codes

    Code Name
    KSH Chamber, Environmental For The Storage Of Platelet Concentrate

    GMDN Terms

    Code Name
    62158 Platelet incubator

    Identifiers

    Type ID
    Primary 00863626000294