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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tracheobronchial suction catheter 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 CodeOFR
Regulation Number 868.6810
Device Class 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 1 1
2021 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Insufficient Information 1 1
Material Integrity Problem 1 1
Gas/Air Leak 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Ventilator Dependent 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
2 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
3 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
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