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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device warmer, peritoneal dialysate
Regulation Description Peritoneal dialysis system and accessories.
Product CodeMLW
Regulation Number 876.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
THERMASOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT - KIT 1

MDR Year MDR Reports MDR Events
2025 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1

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