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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dialysis administration kit
Regulation Description Hemodialysis 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 www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Product CodePEV
Regulation Number 876.5820
Device Class 2

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
2 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2024
4 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
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