FDA Registration
Active
🇺🇸 United States
Airgas Therapeutics LLC
Reg #: 2518435
·
FEI: 2518435
·
Expires 2026
Products
15
Proprietary Names
13
Establishment Types
2
Classifications
15
Registration Details
- Registration Name
- Airgas Therapeutics LLC
- Registration Number
- 2518435
- FEI Number
- 2518435
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6141 Easton Road, P/O. Box 310
- City
- PLUMSTEADVILLE
- State
- PA
- ZIP
- 18949
- Country
- US
Regulatory Submissions
- 510(k) Number
- K212409
- PMA Number
- P900066
Owner / Operator
- Firm Name
- Airgas Therapeutics LLC
- Operator Number
- 10084091
- Address
- 6141 Easton Road, P.O. Box 310
- City
- Plumsteadville
- State
- PA
- Postal Code
- 18949
- Country
- US
- Correspondent
- Timothy Warren
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gases Used Within Eye To Place Pressure On Detached Retina | LPO | Class 3 | Ophthalmic | No | 2022-01-17 |
| Organ Care System (Ocs) Heart System | QIK | Class 3 | Unknown | No | 2024-03-28 |
| Gas, Laser Generating | NXF | Class 1 | General, Plastic Surgery | No | 2022-01-17 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2023-08-07 |
| Analyzer, Nitrogen Dioxide | MRQ | Class 2 | Anesthesiology | No | 2023-08-07 |
| Analyzer, Nitric Oxide | MRP | Class 2 | Anesthesiology | No | 2023-08-07 |
| Apparatus, Nitric Oxide, Backup Delivery | MRO | Class 2 | Anesthesiology | No | 2023-08-07 |
| Apparatus, Nitric Oxide Delivery | MRN | Class 2 | Anesthesiology | No | 2023-08-07 |
| System, Balloon, Intra-Aortic And Control | DSP | Class 2 | Cardiovascular | No | 2022-01-17 |
| Device, Gas Generating | KZJ | Class 1 | Microbiology | No | 2022-01-17 |
| Gas, Calibration (Specified Concentration) | BXK | Class 1 | Anesthesiology | No | 2022-01-17 |
| Regulator, Pressure, Gas Cylinder | CAN | Class 1 | Anesthesiology | No | 2022-01-17 |
| Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation | QQK | Class 3 | Unknown | No | 2024-03-28 |
| Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation | QBA | Class 3 | Unknown | No | 2024-03-28 |
| Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs | PHO | Class 3 | Unknown | No | 2024-03-28 |
Proprietary Names
Organ Care System (OCS) Heart
Laser Gas Mixture
Ulspira TS
ULSPIRA TS
Aerobic Anaerobic Gas Mixture
Calibration Mixture
Slope Gas
Aerobic/Anaerobic Gas Mixture
Lung Diffusion Mixture
Blood gas Mixture
Gas Cylinder Pressure Regulator
OCS Liver
OCS Lung System
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)