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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device container, specimen mailer and storage, temperature controlled, sterile
Product CodeKDW
Regulation Number 864.3250
Device Class 1

MDR Year MDR Reports MDR Events
2018 3 3
2020 3 3
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Leak/Splash 1 1
Incorrect Measurement 1 1
No Device Output 1 1
Material Rupture 1 1
Incorrect Or Inadequate Test Results 1 1
Device Contamination with Chemical or Other Material 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
No Clinical Signs, Symptoms or Conditions 3 3
No Patient Involvement 1 1

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