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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sterilizer, ethylene-oxide gas
Regulation Description Ethylene oxide gas sterilizer.
Product CodeFLF
Regulation Number 880.6860
Device Class 2


Premarket Reviews
ManufacturerDecision
ANDERSEN STERILIZERS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 2 2
Improper Chemical Reaction 1 1
Use of Incorrect Control/Treatment Settings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Headache 3 3
Chemical Exposure 2 2
Dizziness 2 2
Dyspnea 1 1
Eye Pain 1 1
Sore Throat 1 1

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