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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device venous window needle guide
Regulation Description Blood access device and accessories.
Definition For use as an access device accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site or buttonhole method of needle insertion.
Product CodePFH
Regulation Number 876.5540
Device Class 2

Device Problems
Filling problem 1
Gradient increase 1
Insufficient flow or underinfusion 1
Obstruction within device 1
Device operates differently than expected 1
No flow 1
Total Device Problems 6

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