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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
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
5 NxStage Medical, Inc. II Dec-18-2019
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