FDA-Device2025-07-09Class I
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
Philips Respironics, Inc.
Hazard
This device does not indicate for use in patients with respiratory failure.
Sold states
Worldwide distribution: US (Nationwide)including Guam and Puerto Rico; OUS (Foreign) to countries of: United Arab Emirates (AE), Argentina (AR), Austria (AT), Australia (AU), Bosnia and Herzegovina (BA), Belgium (BE), Brazil (BR), Canada (CA), Chile (CL), China (CN), Colombia (CO), Costa Rica (CR), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Hungary (HU), Indonesia (ID), Ireland (IE), India (IN), Italy (IT), Jordan (JO), Japan (JP), Korea, Republic of (KR), Lebanon (LB), Morocco (MA), Monaco (MC), Montenegro (ME), Mexico (MX), Malaysia (MY), Netherlands (NL), Norway (NO), Nepal (NP), Peru (PE), Philippines (PH), Pakistan (PK), Poland (PL), Portugal (PT), Qatar (QA), Romania (RO), Serbia (RS), Russian Federation (RU), Saudia Arabia (SA), Singapore (SG), Slovakia (SK), Thailand (TH), Turkey (TR), Taiwan (TW), Viet Nam (VN), South Africa (ZA).
Affected count
5,958 units
Manufactured in
1001 Murry Ridge Ln, Murrysville, PA, United States
Products
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2035-2025Don't want to check this manually?
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