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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device kidney perfusion kit
Regulation Description Isolated kidney perfusion and transport system and accessories.
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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Product CodePIN
Regulation Number 876.5880
Device Class 2

Device Problems
Other (for use when an appropriate device code cannot be identified) 1
Total Device Problems 1