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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device blood and urine collection kit (excludes hiv testing)
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 CodeOIB
Regulation Number 864.3250
Device Class 1

MDR Year MDR Reports MDR Events
2020 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation II Feb-05-2020
2 Centurion Medical Products Corporation II Oct-31-2019
3 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
4 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
7 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Feb-01-2024
9 MEDLINE INDUSTRIES, LP - Northfield II Nov-16-2023
10 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
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