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510(k) Data Aggregation

    K Number
    K242374
    Device Name
    ULSPIRA TS™ Nitric Oxide Therapy System
    Manufacturer
    Airgas Therapeutics LLC
    Date Cleared
    2025-01-17

    (161 days)

    Product Code
    MRN, CCL, MRO, MRP, MRQ
    Regulation Number
    868.5165
    Why did this record match?
    Applicant Name (Manufacturer) :

    Airgas Therapeutics LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ulspira TS Nitric Oxide Therapy System is intended for use by healthcare professionals for the delivery of nitric oxide (NO) and the monitoring of inspired NO, NO2 and O2 concentrations for a patient undergoing inhaled Nitric Oxide (iNO) therapy. The Ulspira TS must only be used in accordance with the indications, contraindications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates. Refer to this material prior to use. The Ulspira TS primary NO therapy system delivers NO gas in the 0-80 ppm range while in the Constant Rate or flow sensing modes. This includes: · Continuous integrated monitoring for inspired NO, NO2 and a comprehensive alarm system. · A touch-screen user interface with a waveform display of the ventilation device flow as measured in the inspiratory limb. • Cylinder handling facilitated by manual or an automatic cylinder switch which is reactive to the detected gas supply state of NO cylinders, and a low O2 pressure alarm when using an oxygen cylinder. · An automated emergency dosing algorithm activated by certain high-risk alarms, which impact patient dosing, to avoid sudden cessation of therapy. · Compatibility with a wide inspiratory flow rate range of 0.25-120 //min, utilizing an automatically detected low or high flow sensor. · An internal battery which provides at least two hours of uninterrupted therapy and a 12V DC inlet for additional external battery access. The integrated Ulspira TS pneumatic backup NO therapy system provides backup NO delivery capability that is intended to deliver a continuous flow of NO mixed with O2, for iNO therapy which allows continuous treatment during transit within hospitals.
    Device Description
    Ulspira TS Nitric Oxide Therapy System delivers physician-prescribed NO therapy gas and monitors inspired Nitric Oxide, Nitrogen Dioxide, and Oxygen gas in combination with a respiratory device. The main device functionalities of the Ulspira TS Nitric Oxide Therapy System include: - A primary delivery system to administer NO gas into a respiratory device circuit. - Monitoring of NO, NO2, and O2 gas concentrations close to the patient interface. - System includes a user interface that contains all controls used to set the NO delivery and monitoring parameters. All set parameters as well as other information are shown on the user interface screen. - The system will produce visual and audible alarms if vital parameters vary beyond preset or default limits. - The system includes an integrated pneumatic back-up system for manual hand bagging in order to deliver NO therapy in the event of a failure of the primary delivery system and during manual ventilation. The Ulspira TS system consists of the base unit, the mobile cart and bedside rail holder, and various components and accessories, including the gas regulators and patient kits for use with validated respiratory devices.
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