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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, non-sterile
Product CodeNNL
Regulation Number 864.3250
Device Class 1

MDR Year MDR Reports MDR Events
2016 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Off-Label Use 1 1
Inadequate or Insufficient Training 1 1
Use of Device Problem 1 1
Activation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 1 1
Insufficient Information 1 1

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