BEUDAMED
    FDA Registration Active 🇺🇸 United States

    A7 Anesthesia System

    Reg #: 2221819 · FEI: 2221819 · Expires 2025
    View on FDA
    Products
    10
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    10

    Registration Details

    Registration Name
    MINDRAY DS USA, Inc.
    Registration Number
    2221819
    FEI Number
    2221819
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    800 MACARTHUR BLVD.
    City
    Mahwah
    State
    NJ
    ZIP
    07430
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171292

    Owner / Operator

    Firm Name
    Mindray DS USA, Inc.
    Operator Number
    10025908
    Address
    800 MacArthur Blvd
    City
    Mahwah
    State
    NJ
    Postal Code
    07430
    Country
    US
    Correspondent
    James Clifford

    Products

    Device Name Product Code
    Gas-Machine, Anesthesia BSZ
    Regulator, Vacuum KDP
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR

    Proprietary Names

    A7 Anesthesia System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer)