Data / Medical devices / United States / Beyond Air Inc.
Beyond Air Inc.: FDA-registered device maker in Garden City, NY, United States, 1 PMA approval
Beyond Air Inc. is registered with the FDA (registration 3020846279) in Garden City, NY, United States. It lists 2 device types. The FDA files 1 PMA approval under its listings, the newest dated June 28, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3020846279
- Address
- 900 Stewart Avenue, Suite 301, Garden City, NY, United States, 11530
- Owner or operator
- Beyond Air Inc. (10085702)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- July 22, 2022
- Registered through
- 2027
- Brand names listed
- 10mm Gas Sample Adaptor Kit (90006), 15mm Gas Sample Adaptor Kit (90007), 22mm Gas Sample Adaptor Kit (90017), Luer Elbow 7.6mm Port Kit (90016), LungFit® PH Bagging Kit (90005), LungFit® PH NDM Assembly (90014), LungFit® PH NO2 Filter (90008), LungFit® PH Verification Kit (90015) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Gas, Calibration (Specified Concentration) | BXK | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Nitric Oxide Generator And Delivery System | QTB | 3 | Complaint file establishment, Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 28, 2022 | P200044 | LungFit PH | QTB | 10 | March 13, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Nitric Oxide Generator And Delivery System
- All makers of Gas, Calibration (Specified Concentration)
Updated March 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.