10 results
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48ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BodyGuardian Mini Plus Remote Monitoring System Kit
FDA UDI
Preventice Services, LLC·00850028319031·
PER900 Monitoring System Kit
FDA UDI
Preventice Services, LLC·00850028319055·
BodyGuardian Heart Remote Monitoring System Kit
FDA UDI
Preventice Services, LLC·00850028319017·
Mortara H3+ Monitoring System Kit
FDA UDI
Preventice Services, LLC·00850028319048·
BodyGuardian One Remote Monitoring System Kit
FDA UDI
Preventice Services, LLC·00850028319000·
BodyGuardian Mini Remote Monitoring System Kit
FDA UDI
Preventice Services, LLC·00850028319024·
BODYGUARDIAN MINI EL
FDA Adverse Event
Injury
·PREVENTICE SERVICES, LLC·Product code DSI·January 27, 2022
BODYGUARDIAN HEART
FDA Adverse Event
Injury
·PREVENTICE SERVICES, LLC·Product code DSI·August 12, 2019
BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and a cell phone, either Models BP1008 or BP10014, that is paired to both of the monitors.
FDA Recall
Terminated
·Preventice Services, LLC·Product code DSI·August 6, 2019
BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and a cell phone, either Models BP1008 or BP10014, that is paired to both of the monitors.
FDA Enforcement
Class II
·Terminated·Preventice Services, LLC·July 8, 2020