Ulspira TS IN000102
GUDID 03760333380671
ULSPIRA TS Nitric Oxide Therapy System - Base Unit and Mobile Cart
Airgas Therapeutics, LLC
Nitric oxide delivery unit, system-based| Primary Device ID | 03760333380671 |
| NIH Device Record Key | eae477ea-f328-48e3-a73b-44ec9c96fe53 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ulspira TS |
| Version Model Number | ULSPIRA TS |
| Catalog Number | IN000102 |
| Company DUNS | 118537769 |
| Company Name | Airgas Therapeutics, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03760333380671 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K212409
FDA Product Code
| MRN | Apparatus, Nitric Oxide Delivery |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-10 |
| Device Publish Date | 2024-01-02 |
Devices Manufactured by Airgas Therapeutics, LLC
| 00819601025653 - Scott Medical Products | 2025-05-30 Description: 5% CO2, 15% O2, BAL. N2; Cylinder: K; Valve: CGA 500; For calibration of medical analyzers in accordance with man |
| 10819601025667 - BVI Medical | 2025-05-28 ISPAN Gas, Sulfur Hexafluoride (SF6); Cylinder: LD1; Valve: CGA 180; Retinal tamponade for use in pneumatic retinopexy. |
| 10819601025674 - BVI Medical | 2025-05-28 ISPAN Gas, Sulfur Hexafluoride (SF6); Cylinder: LD2; Valve: CGA 180; Retinal tamponade for use in pneumatic retinopexy. |
| 10819601025681 - BVI Medical | 2025-05-28 ISPAN Gas, Sulfur Hexafluoride (SF6); Cylinder: LD2; Valve: CGA 170; Retinal tamponade for use in pneumatic retinopexy. |
| 10819601025698 - BVI Medical | 2025-05-28 ISPAN Gas, Perfluoropropane (C3F8); Cylinder: LD1; Valve: CGA 180; Retinal tamponade for use in pneumatic retinopexy. |
| 10819601025704 - BVI Medical | 2025-05-28 ISPAN Gas, Perfluoropropane (C3F8); Cylinder: LD2; Valve: CGA 180; Retinal tamponade for use in pneumatic retinopexy. |
| 10819601025711 - BVI Medical | 2025-05-28 ISPAN Gas, Perfluoropropane (C3F8); Cylinder: LD2; Valve: CGA 165; Retinal tamponade for use in pneumatic retinopexy. |
| 00819601025493 - Jaeger Medical | 2025-05-09 Description: 4% CO2, 16% O2, BAL N2; Cylinder: ED; Valve: CGA 973; For use with Jaeger Medical's Pulmonary Function Diagnostic |
Trademark Results [Ulspira TS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ULSPIRA TS 98320149 not registered Live/Pending |
Airgas Therapeutics, LLC 2023-12-18 |
 ULSPIRA TS 97932477 not registered Live/Pending |
Airgas Therapeutics, LLC 2023-05-11 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.