7 results
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46ms
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Sources: EU EUDAMED, US FDA
Oxus America, Inc.
FDA registration
Oxus America, Inc.·1 product·🇺🇸 United States
Oxus / GCE
FDA UDI
OXUS AMERICA, INC.·00867460000137·Zen-O Lite Portable Oxygen Concentrator
Oxus / GCE
FDA UDI
OXUS AMERICA, INC.·00867460000144·Zen-O™ Clarity Portable Oxygen Concentrator
Oxus / GCE
FDA UDI
OXUS AMERICA, INC.·00867460000106·Zen-O™ Portable Oxygen Concentrator
Oxus Refurbished Sieve Bed
FDA UDI
OXUS AMERICA, INC.·00867460000120·Inogen One G3 Replacement Sieve Beds
Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.
FDA Recall
Terminated
·Oxus America, Inc.·Product code CAW·January 14, 2013
Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.
FDA Enforcement
Class II
·Terminated·Oxus America, Inc.·February 13, 2013