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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
Regulation Description Tracheobronchial suction catheter.
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
2020 1 1
2021 1 1
2024 1 1

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
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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