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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)
Regulation Description Specimen transport and storage container.
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
2018 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Sticking 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation II Feb-05-2020
2 Centurion Medical Products Corporation II Oct-31-2019
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