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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, peritoneal, long-term indwelling, exempt
Definition This product code is the class II exempt counterpart of FJS, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Product CodePTU
Regulation Number 876.5630
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1 1

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