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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device blood transfusion kit
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodePOQ
Regulation Number 880.5440
Device Class 2

MDR Year MDR Reports MDR Events
2021 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Device Damaged Prior to Use 11 11
Manufacturing, Packaging or Shipping Problem 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Insufficient Information 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Combat Medical Systems, LLC I Feb-19-2021
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