FDA Registration
Active
🇺🇸 United States
BEYOND AIR INC.
Reg #: 3020846279
·
FEI: 3020846279
·
Expires 2026
Products
1
Proprietary Names
10
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- BEYOND AIR INC.
- Registration Number
- 3020846279
- FEI Number
- 3020846279
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 900 Stewart Avenue, Suite 301
- City
- Garden City
- State
- NY
- ZIP
- 11530
- Country
- US
Regulatory Submissions
- PMA Number
- P200044
Owner / Operator
- Firm Name
- Beyond Air Inc.
- Operator Number
- 10085702
- Address
- 900 Stewart Avenue, Suite 301
- City
- Garden City
- State
- NY
- Postal Code
- 11530
- Country
- US
- Correspondent
- Rhona Shanker
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nitric Oxide Generator And Delivery System | QTB | Class 3 | Unknown | No | 2022-07-22 |
Proprietary Names
22mm Gas Sample Adaptor Kit (90017)
LungFit® PH Bagging Kit (90005)
LungFit® PH (90002)
Sample Line Kit (90031)
Luer Elbow 7.6mm Port Kit (90016)
10mm Gas Sample Adaptor Kit (90006)
LungFit® PH NDM Assembly (90014)
LungFit® PH Verification Kit (90015)
15mm Gas Sample Adaptor Kit (90007)
LungFit® PH NO2 Filter (90008)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility