BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    i.Series Platelet Incubator

    DI: 00816394021671 · Model: PC3200-PRO · HELMER, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    i.Series Platelet Incubator
    Primary DI
    00816394021671
    Version / Model
    PC3200-PRO
    Company Name
    HELMER, INC.
    Labeler DUNS
    086685682
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-01
    Public Version
    1
    Public Version Date
    2022-12-09
    Public Version Status
    New
    Public Device Record Key
    1107741b-66b6-4b63-b37f-6e015e353499

    Device Description

    Environmentatal chamber for storage of platelet concentrate

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    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 00816394021671