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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device whole room microbial reduction device
Definition A whole room microbial reduction device is a medical device to be used to reduce microbial load on medical device surfaces following cleaning and disinfection.
Product CodeQXJ
Regulation Number 880.6510
Device Class 2


Premarket Reviews
ManufacturerDecision
PREVENTAMED TECHNOLOGIES, INC. DBA SURFACIDE MANUFACTURING
  SUBSTANTIALLY EQUIVALENT 1
XENEX DISINFECTION SERVICES, INC.
  GRANTED 1

Recalls
Manufacturer Recall Class Date Posted
1 XENEX Disinfection Services Inc. II Apr-23-2024
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