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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device port introducer 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 CodeOKE
Regulation Number 880.5965
Device Class 2

MDR Year MDR Reports MDR Events
2018 4 4
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Detachment Of Device Component 1 1
Fluid/Blood Leak 1 1
Tear, Rip or Hole in Device Packaging 1 1
Chemical Spillage 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
No Information 2 2
Chemical Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems, Inc. II Jan-26-2024
2 American Contract Systems, Inc. II Sep-08-2022
3 Cardinal Health 200, LLC II Oct-10-2023
4 Tri-State Hospital Supply Corporation II Jul-07-2009
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