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67ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ProtectX
FDA UDI
The Azac Group·20860005250060·AAMI LEVEL 3 DISPOSABLE PROTECTIVE GOWN OVER TH...
ProtectX
FDA UDI
The Azac Group·20860005250039·AAMI LEVEL 3 DISPOSABLE PROTECTIVE GOWN OVER TH...
Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or insufficiency. The ventilator is equipped with at least 2, NiMH battery modules (Part No. 6487180) which automatically supply 12V DC Power in case of an AC power failure, ensuring that ventilator settings and stored data remain intact in the event of an AC power failure. The battery modules give the user a possibility to use the SERVO-i during intra-hospital transportation.
FDA Enforcement
Class I
·Terminated·Maquet Cardiovascular Us Sales, Llc·May 8, 2013
Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or insufficiency. The ventilator is equipped with at least 2, NiMH battery modules (Part No. 6487180) which automatically supply 12V DC Power in case of an AC power failure, ensuring that ventilator settings and stored data remain intact in the event of an AC power failure. The battery modules give the user a possibility to use the SERVO-i during intra-hospital transportation.
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code CBK·March 7, 2013