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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, non-sterile
Regulation Description Specimen transport and storage container.
Product CodeNNK
Regulation Number 864.3250
Device Class 1

MDR Year MDR Reports MDR Events
2021 4 4
2022 1 1
2023 1 1
2024 3 3
2025 3 3
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 1 1
Crack 1 1
Product Quality Problem 1 1
Material Separation 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
Insufficient Information 3 3
Cholangitis 1 1
Liver Failure 1 1
Urticaria 1 1
Ambulation or Postural Difficulties 1 1
Neuropathy 1 1

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