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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, germicidal, ultraviolet
Product CodeMKB
Regulation Number 880.6500
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2022 3 3
2023 9 9
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 13 13
No Apparent Adverse Event 1 1
Break 1 1
Failure to Power Up 1 1
Patient-Device Incompatibility 1 1
Battery Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Respiratory Distress 1 1
Visual Disturbances 1 1
No Known Impact Or Consequence To Patient 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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