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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, retention, barium enema with bag
Regulation Description Gastrointestinal tube and accessories.
Product CodeFGD
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
CHESS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 1 1
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 1 1
Failure to Deflate 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 1 1
Hypersensitivity/Allergic reaction 1 1
Skin Tears 1 1
Embolism/Embolus 1 1
Skin Inflammation/ Irritation 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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