Ulspira TS
The Ulspira TS delivers prescribed inhaled nitric oxide through a validated respiratory device and monitors inspired nitric oxide, nitrogen dioxide and oxygen near the patient interface.…
The Ulspira TS delivers prescribed inhaled nitric oxide through a validated respiratory device and monitors inspired nitric oxide, nitrogen dioxide and oxygen near the patient interface. Healthcare professionals use it for neonates over 34 weeks gestation with hypoxic respiratory failure and clinical or echocardiographic evidence of pulmonary hypertension.
The base unit provides controls for delivery and monitoring, displays settings and gives visual and audible alarms when parameters cross their limits. An integrated pneumatic backup delivers nitric oxide mixed with oxygen during manual ventilation or failure of the primary delivery system.
Listed Item
ULSPIRA TS Nitric Oxide Therapy System – Base Unit and Mobile Cart
Clinical Setting
The system is intended for neonatal intensive care and neonatal transport. Its use must follow the indications, contraindications, warnings and precautions in the nitric oxide drug labelling. The mobile cart supports the base unit and associated components.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| AOK Tooling Limited | Shen Zhen | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Airgas Therapeutics LLC, United States |
|---|---|
| FDA product code | MRN |
| Device type | Apparatus, Nitric Oxide Delivery |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5165 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K212409 |
| Record published | 2024-01-02 |
| Record revised | 2026-05-06 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ULSPIRA TS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| INOmax | Mallinckrodt Manufacturing LLC | 18 |
| Genosyl® | Vero Biotech Inc. | 17 |
| NOxBOXi Noxkit | Vero Biotech Inc. | 7 |
| AeroNOx 2.0 Nitric Oxide Delivery Device | International Biomedical, Ltd. | 1 |
| AeroNOx Nitric Oxide Delivery Device | International Biomedical, Ltd. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242374 | 2025-01-17 |
| K212409 | 2023-06-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.