BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Salaera d.b.a Perma Pure

    Reg #: 2244684 · FEI: 2244684 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

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    Registration Details

    Registration Name
    Salaera d.b.a Perma Pure
    Registration Number
    2244684
    FEI Number
    2244684
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1001 New Hampshire Avenue, Unit B
    City
    Lakewood
    State
    NJ
    ZIP
    08701
    Country
    US

    Regulatory Submissions

    510(k) Number
    K881264

    Owner / Operator

    Firm Name
    Salaera, LLC d.b.a Perma Pure
    Operator Number
    2244684
    Address
    1001 New Hampshire Avenue, Unit B
    City
    Lakewood
    State
    NJ
    Postal Code
    08701
    Country
    US

    Products

    Device Name Product Code
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT

    Proprietary Names

    O2asis Humidifier

    Establishment Types

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