BEUDAMED
    Product Code: MRN FDA class 2 21 CFR 868.5165

    Apparatus, Nitric Oxide Delivery

    Anesthesiology

    The Nitric Oxide Delivery Apparatus is an anesthesiology device used to deliver precise concentrations of inhaled nitric oxide (iNO) gas to mechanically ventilated patients, primarily for the treatment of pulmonary hypertension in neonates and adults by causing selective pulmonary vasodilation. Classified as FDA Class 2 under 21 CFR 868.5165, it requires 510(k) premarket notification. The product code is MRN, and it carries a life-sustaining support flag reflecting the critical role of iNO therapy.

    View on FDA
    510(k)s
    33
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    18
    Years Active
    25

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    Basic Information

    Product Code
    MRN
    Device Class
    FDA class 2
    Regulation Number
    868.5165
    Medical Specialty
    Anesthesiology
    Review Panel
    AN
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✓
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 33 510(k) clearances via K numbers.

    K Number Device Name
    K242374 ULSPIRA TS™ Nitric Oxide Therapy System
    K242578 EVOLVE Nitric Oxide Delivery System
    K240410 EVOLVE Nitric Oxide Delivery System
    K233251 NOxBOXi Nitric Oxide Delivery System
    K222930 Evolve Nitric Oxide Delivery System
    K231823 NOxBOXi Nitric Oxide Delivery System
    K212409 Ulspira TS Nitric Oxide Therapy System
    K211153 Inomax DSIR
    K220898 NOxBOXi Nitric Oxide Delivery System
    K201339 The NOxBOXi Nitric Oxide Delivery System
    K200389 INOmax DSIR Plus
    K193481 AeroNOx 2.0 Nitric Oxide Titration & Monitoring System
    K171696 NOxBOXi Nitric Oxide Delivery System
    K143213 INOmax DSIR Plus MRI
    K131686 INOMAX DSIR (DELIVERY SYSTEM)
    K130605 INOMAX DSIR (DELIVERY SYSTEM)
    K121021 INOMAX DS (DELIVERY SYSTEM)
    K120216 GENOSYL MV-1000
    K113272 INOMAX DS(DELIVERY SYSTEMS
    K110344 INOMAX DSIR (DELIVERY SYSTEM)
    K110635 INOMAX DS(IR) (DELIVERY SYSTEM)
    K093922 INOMAX DS
    K092545 INOMAX DS (DELIVERY SYSTEM), MODEL 10003
    K093260 AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM
    K081691 INOMAX DS (DELIVERY SYSTEM)
    K080484 INOMAX DS (DELIVERY SYSTEM), MODEL 10003
    K071516 INOMAX DS
    K070867 INOMAX DS (DELIVERY SYSTEM), MODEL 10003
    K061901 INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003
    K033779 VIANOX DELIVERY SYSTEM, MODEL II
    K000653 AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002
    K000186 DATEX-OHMEDA INOVENT DELIVERY SYSTEM
    DEN000001 OHMEDA INOVENT DELIVERY SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.