2 results
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68ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.
FDA Enforcement
Class II
·Terminated·Linde Gas North America Llc·June 26, 2013
MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.
FDA Recall
Terminated
·Linde Gas North America Llc
575 Mountain Ave
Attn Import Compliance Manager
New Providence NJ 07974·Product code CAN·March 8, 2013