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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device arterial blood sampling 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 type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeCBT
Regulation Number 868.1100
Device Class 1

MDR Year MDR Reports MDR Events
2014 6 6
2015 10 10
2016 30 30
2017 22 22
2018 15 15
2019 19 19
2020 10 10
2021 24 24
2022 10 10

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health II Sep-02-2016
2 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
3 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
4 SunMed Holdings, LLC II Sep-23-2022
5 Vyaire Medical II Aug-28-2017
6 Westmed Inc II Oct-20-2012
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