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Sign in to claim this brandAirgas Therapeutics
United States·US-MF-000032722
Last updated May 23, 2026
What Airgas Therapeutics makes
Airgas Therapeutics manufactures calibration gas cylinders, including both non-refillable and refillable variants, used primarily for medical and laboratory applications. They also produce vitreous and aqueous humour replacement media for intraoperative use, as well as intraocular gas cylinder regulators. Additionally, the company supplies system-based nitric oxide delivery units for respiratory therapy.
The company’s portfolio includes devices classified as Class I, Class II, and Class III under regulatory frameworks. These products are listed in eudamed, FDA’s 510(k) premarket notification database, and the FDA’s Unique Device Identifier (UDI) registry. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Airgas Therapeutics manufacture?
Airgas Therapeutics specializes in calibration gases for medical and laboratory use, including non-refillable and refillable cylinders. Their portfolio also includes intraoperative vitreous and aqueous humour replacement media, intraocular gas cylinder regulators, and system-based nitric oxide delivery units for respiratory therapy. These products serve critical roles in diagnostics, surgical procedures, and patient care.
Where is Airgas Therapeutics based, and how does that affect its regulatory compliance?
Airgas Therapeutics is based in the United States, which means its devices must comply with FDA regulations. The company’s products are listed in the FDA’s 510(k) premarket notification database and the UDI registry, demonstrating adherence to U.S. regulatory requirements. Additionally, some devices are included in the EU’s eudamed database, reflecting their global market presence and compliance with EU regulatory standards.
Which regulatory registries list Airgas Therapeutics’ devices, and why is this important?
Airgas Therapeutics’ devices appear in three key registries: eudamed (for EU market compliance), the FDA’s 510(k) database (for U.S. premarket notifications), and the FDA’s UDI registry (for unique device identification). Listing in these databases ensures transparency, traceability, and compliance with global regulatory frameworks, which are essential for market authorization, post-market surveillance, and patient safety.
How are Airgas Therapeutics’ devices classified under regulatory standards?
Airgas Therapeutics’ devices are classified as Class I, Class II, or Class III under regulatory frameworks. Class I devices generally pose the lowest risk (e.g., simple calibration cylinders), while Class II and Class III devices involve higher risks (e.g., intraoperative media or nitric oxide delivery systems) and require stricter premarket evaluations or approvals. The classification determines the regulatory pathway, including documentation requirements and oversight intensity.
Why do some of Airgas Therapeutics’ devices appear in multiple regulatory registries?
Devices listed in multiple registries—such as eudamed, FDA 510(k), and UDI—are typically marketed in both the European Union and the United States. The inclusion in these databases reflects the company’s compliance with distinct regulatory systems: eudamed for EU market access, FDA registries for U.S. authorization, and UDI for global traceability. This ensures devices meet the specific requirements of each market while maintaining consistency in safety and performance standards.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 6141, Easton Road, Plumsteadville, United States
- Website
- www.scottmedicalproducts.com
- —
- —
- [email protected]
- Phone
- +1 215 766 8860
- PRRC Contact
- Timothy Warren
- EUDAMED SRN
- US-MF-000032722
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (88)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Scott Medical Products | Calibration Gas | FDA UDI | Class I | Active |
| Scott Medical Products | Calibration Gas | FDA UDI | Class I | Active |
| Scott Medical Products | Anesthesia Calibration Gas | FDA UDI | Class I | Active |
| GE Healthcare | Calibration Gas | FDA UDI | Class I | Active |
| Datalink S&T | Calibration Gas | FDA UDI | Class I | Active |
| Jaeger Medical | Pulmonary Function Calibration Gas | FDA UDI | Class I | Active |
| Siemens | Calibration Gas | FDA UDI | Class I | Active |
| Jaeger Medical | Pulmonary Function Calibration Gas | FDA UDI | Class I | Active |
| Bionostic, Inc. | Calibration Gas | FDA UDI | Class I | Active |
| Jaeger Medical | Pulmonary Function Calibration Gas | FDA UDI | Class I | Active |
| Scott Medical Products | Calibration Gas | FDA UDI | Class I | Active |
| BVI Medical | ISPAN | FDA UDI | Class III | Active |
| Jaeger Medical | Pulmonary Function Calibration Gas | FDA UDI | Class I | Active |
| Ulspira TS | ULSPIRA TS | FDA UDI | Class II | Active |
| Scott Medical Products | Calibration Gas | FDA UDI | Class I | Active |
| GE Healthcare | Calibration Gas | FDA UDI | Class I | Active |
| Siemens | Calibration Gas | FDA UDI | Class I | Active |
| Scott Medical Products | Calibration Gas | FDA UDI | Class I | Active |
| Scott Medical Products | Anesthesia Calibration Gas | FDA UDI | Class I | Active |
| Bionostic, Inc. | Calibration Gas | FDA UDI | Class I | Active |
| Datalink S&T | Calibration Gas | FDA UDI | Class I | Active |
| Jaeger Medical | Pulmonary Function Calibration Gas | FDA UDI | Class I | Active |
| BVI Medical | ISPAN | FDA UDI | Class III | Active |
| GE Healthcare | Calibration Gas | FDA UDI | Class I | Active |
| Scott Medical Products | Pulmonary Function Gas | FDA UDI | Class I | Active |
| Diamond Diagnostics | Calibration Gas | FDA UDI | Class I | Active |
| Scott Medical Products | Calibration Gas | FDA UDI | Class I | Active |
| Bionostic, Inc. | Calibration Gas | FDA UDI | Class I | Active |
| Bionostic, Inc. | Calibration Gas | FDA UDI | Class I | Active |
| Bionostic, Inc. | Calibration Gas | FDA UDI | Class I | Active |
| Jaeger Medical | Pulmonary Function Calibration Gas | FDA UDI | Class I | Active |
| Bionostic, Inc. | Calibration Gas | FDA UDI | Class I | Active |
| Bionostic, Inc. | Calibration Gas | FDA UDI | Class I | Active |
| ULSPIRA TS™ Nitric Oxide Therapy System | K242374 | FDA 510(k) | Class II | Active |
| Ulspira TS Nitric Oxide Therapy System | K212409 | FDA 510(k) | Class II | Active |
| Respiratory Calibration Gas | Z03NI808EDC007 | EUDAMED | Class I | Active |
| Ispan Sulfur Hexafluoride Sf6 Gas | P900067 | FDA PMA | Class III | Active |
| Perfluoropropane For Pneumatic Retinopexy | P900066 | FDA PMA | Class III | Active |
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