BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe

    Reg #: 3014759854 · FEI: 3014759854 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CERTA DOSE
    Registration Number
    3014759854
    FEI Number
    3014759854
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2590 Welton Street, #200
    City
    Denver
    State
    CO
    ZIP
    80205
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160589

    Owner / Operator

    Firm Name
    CD Acquisitions, LLC (Certa Dose)
    Operator Number
    10058186
    Address
    2590 Welton Street, #200
    City
    Denver
    State
    CO
    Postal Code
    80205
    Country
    US
    Correspondent
    Caleb Hernandez

    Products

    Device Name Product Code
    Epinephrine Syringe PQX

    Proprietary Names

    Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility