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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tracheotomy care 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 CodeNXA
Regulation Number 868.5800
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2022 4 4
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Component Missing 2 2
Contamination /Decontamination Problem 1 1
Corroded 1 1
Device Contamination with Chemical or Other Material 1 1
Fitting Problem 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
No Known Impact Or Consequence To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Busse Hospital Disposables, Inc. I Jan-03-2024
2 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
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