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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device emergency response safety 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 CodeOKI
Regulation Number 878.4040
Device Class 2

MDR Year MDR Reports MDR Events
2014 1 1
2017 1 1
2022 2 2
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 3 3
Component Missing 2 2
Device Dislodged or Dislocated 1 1
Filling Problem 1 1
Difficult to Remove 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Extubate 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

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