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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, pasteurization, hot water
Product CodeLDS
Regulation Number 880.6991
Device Class 2


Premarket Reviews
ManufacturerDecision
CENORIN, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Thermal Decomposition of Device 1 1
Fluid/Blood Leak 1 1
Melted 1 1
Device Slipped 1 1
Sparking 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cenorin II Oct-12-2010
2 Cenorin, LLC II Jun-26-2018
3 Cenorin, LLC II Jul-06-2014
4 Cenorin, LLC II Jun-06-2014
5 Natus Medical Incorporated II Jun-01-2016
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