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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device venipuncture kit
Regulation Description Hypodermic single lumen needle.
Definition This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 CodePXL
Regulation Number 880.5570
Device Class 2

MDR Year MDR Reports MDR Events
2017 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Needle Stick/Puncture 1 1

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