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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, vein location, liquid crystal
Product CodeKZA
Regulation Number 880.6970
Device Class 1


Premarket Reviews
ManufacturerDecision
NOVARIX LIMITED
  SUBSTANTIALLY EQUIVALENT 1
VUETEK SCIENTIFIC LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 2 2
2018 3 3
2019 1 1
2020 1 1
2022 1 1
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4 4
Detachment Of Device Component 1 1
Crack 1 1
Positioning Failure 1 1
No Display/Image 1 1
Product Quality Problem 1 1
Defective Component 1 1
Component Missing 1 1
Structural Problem 1 1
Battery Problem 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 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 4 4
No Information 2 2
Laceration(s) 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Christie Medical Holding Inc II Mar-22-2012
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