Vero Biotech Inc.
Livingston, TN, US
VERO BIOTECH INC. appears in FDA device records in Livingston, TN. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012160128 | 3012160128 | VERO BIOTECH INC. | 208 N Main St, Livingston, TN 38570 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0564-2024 | VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for inhalation at the point of use | Cassette did not meet an 1n-process flow criterion. | Class II | Open, Classified | |
| Z-2587-2021 | GENOSYL DS (Delivery System) console, for use as a vasodilator. | Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO). | Class I | Completed | |
| Z-1863-2021 | GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860 | Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field. | Class I | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain