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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device purifier, air, ultraviolet, medical
Product CodeFRA
Regulation Number 880.6500
Device Class 2


Premarket Reviews
ManufacturerDecision
AEROBIOTIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
AEROCLEAN TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AEROCLEAN TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
AERUS MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
AIRGLE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BLUEZONE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENESIS AIR, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU AJAX MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HGI INDUSTIRES
  SUBSTANTIALLY EQUIVALENT 1
INVICTUS LIGHTING
  SUBSTANTIALLY EQUIVALENT 1
MOLEKULE, INC.
  SUBSTANTIALLY EQUIVALENT 3
SAMSUNG ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYNEXIS, LLC
  SUBSTANTIALLY EQUIVALENT 1
TRANSFORMAIR, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2021 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Sensing Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Device Difficult to Maintain 1 1

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

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