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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device airway monitoring system
Definition The device is intended to assist in verifying ett tube placement, assist in detecting ett tube movement and obstruction of the tube tip
Product CodeOQU
Regulation Number 868.5730
Device Class 2


Premarket Reviews
ManufacturerDecision
SONARMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 3 3
Obstruction of Flow 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien, LP II Jan-19-2022
2 SonarMed Inc I Apr-19-2024
3 SonarMed Inc I Apr-18-2024
4 SonarMed Inc II Sep-04-2019
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