BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CHARTER MEDICAL, LLC

    Reg #: 1066733 · FEI: 3002910717 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    8

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    Registration Details

    Registration Name
    CHARTER MEDICAL, LLC
    Registration Number
    1066733
    FEI Number
    3002910717
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3948-A WEST POINT BLVD.
    City
    Winston Salem
    State
    NC
    ZIP
    27103
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK100049

    Owner / Operator

    Firm Name
    CHARTER MEDICAL, LLC.
    Operator Number
    2246665
    Address
    195 O'Neill Drive
    City
    Quakertown
    State
    PA
    Postal Code
    18951
    Country
    US
    Correspondent
    Kitu Patel

    Products

    Device Name Product Code
    Container, Frozen Donor Tissue Storage LPZ
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Microfilter, Blood Transfusion CAK
    Set, Transfer (Blood/Plasma) KSB
    Container, Empty, For Collection & Processing Of Blood & Blood Components KSR
    Set, Blood Transfusion BRZ
    Syringe, Piston FMF
    System, Suspension, Cell Culture KJF

    Proprietary Names

    Cell Freeze Cryogenic Storage Container Tru-Flo Neo-40 Syringe Set Blood Transfer Set Advect Fluid Transfer Set Blood Transfer Bag Neonatal Syringe Set EXP-Pak¿ Cell Expansion Bio-Containers

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)