BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Z-MEDICA, LLC

    Reg #: 3004138549 · FEI: 3004138549 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    7
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    Z-MEDICA, LLC
    Registration Number
    3004138549
    FEI Number
    3004138549
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4 FAIRFIELD BLVD.
    City
    Wallingford
    State
    CT
    ZIP
    06492
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123387

    Owner / Operator

    Firm Name
    Z-MEDICA, LLC
    Operator Number
    9048106
    Address
    4 FAIRFIELD BLVD., --
    City
    Wallingford
    State
    CT
    Postal Code
    06492
    Country
    US
    Correspondent
    Divya Raman

    Products

    Device Name Product Code
    Hemostatic Wound Dressing Without Thrombin Or Other Biologics QSY
    Temporary, Internal Use Hemostatic POD
    Gauze / Sponge,Nonresorbable For External Use NAB

    Proprietary Names

    QuikClot Hemostatic Dressings, QuikClot 2x2, QuikClot 4x4, QuikClot TraumaPad, QuikClot Z-Fold, QuikClot Roll QuikClot Radial QuickClot Control+ Hemostatic Device QuikClot Combat Gauze, QuikClot EMS, QuikClot Combat Gauze TraumaPad, QuikClot Bleeding Control Dressing QuikClot Control+ QuikClot Interventional Phokus Nonwoven Bandage

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)