FDA-Device2023-12-27Class II

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

Vero Biotech, LLC
Hazard

Cassette did not meet an 1n-process flow criterion.

Sold states
US: AZ and FL
Affected count
2 cassettes
Manufactured in
387 Technology Cir Nw Ste 125, N/A, Atlanta, GA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0564-2024

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