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MiniBox
PULMONE ADVANCED MEDICAL DEVICES LTD · Model MiniBox · UDI-DI 07290016675009
1
510(k) clearances
67
Adverse events
5
Recalls
33
Facilities
Description
The MiniBox is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes ). The MiniBox is to be used by either a physician, respiratory therapist, or technician. A cleared single-use, disposable viral-bacterial filter separates the patient from the internal components of the device.The MiniBox measures all common spirometric measurements as well as relative and absolute lung volumes.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-08 | Vyaire Medical, Inc. | Potential of the nozzle separating during patient use. |
| 2016-05-13 | Innovision A/S | The purpose of the recall is to replace data transmission cable (USB-cable) connecting the lnnocor device with an external computer. The replacement USB cable will provide galvani |
| 2009-11-19 | Philips Healthcare Inc. | Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical de |
| 2009-11-19 | Philips Healthcare Inc. | Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical de |
| 2009-11-19 | Philips Healthcare Inc. | Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical de |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.