Product Overview

INOmax DSIR Plus
INOmax DSIR Plus - 10007


Device Description

A mains electricity (AC-powered) device, which may include internal rechargeable batteries, intended for the delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of neonate, paediatric, and adult patients to treat severe respiratory disorders [e.g., primary pulmonary hypertension (PPH), acute respiratory distress syndrome (ARDS)]. It consists of a portable main unit that enables the delivery and monitoring of NO to gases that are to be breathed by the patient via a ventilator or other respiratory device/system. It typically includes accessory items (e.g., tubing, filters) and possibly a trolley (cart) for mobility.


Environmental Conditions

  • Handling Environment Atmospheric Pressure - KiloPascal
    • 110.00
    • 57.00
  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 15.00
  • Handling Environment Temperature - Degrees Celsius
    • 40.00
    • 5.00
  • Special Storage Condition, Specify
    • Could be "Do not subject to sunlight" or "transport only in closed trucks" etc.
  • Storage Environment Atmospheric Pressure - KiloPascal
    • 110.00
    • 57.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 15.00
  • Storage Environment Temperature - Degrees Celsius
    • 60.00
    • -20.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: MRQ

    Device Name: Analyzer, Nitrogen Dioxide

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: AN

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: Y

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 868.2385

    Third Party Flag: Y

    Medical Specialty: AN


    Code: MRO

    Device Name: Apparatus, Nitric Oxide, Backup Delivery

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: AN

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: Y

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 868.5165

    Third Party Flag: N

    Medical Specialty: AN


    Code: MRP

    Device Name: Analyzer, Nitric Oxide

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: AN

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 868.2380

    Third Party Flag: N

    Medical Specialty: AN


    Code: MRN

    Device Name: Apparatus, Nitric Oxide Delivery

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: AN

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: Y

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 868.5165

    Third Party Flag: N

    Medical Specialty: AN


    Device Identifiers

    Device Id: 00867538000106

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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