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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mask, gas, anesthetic
Regulation Description Anesthetic gas mask.
Product CodeBSJ
Regulation Number 868.5550
Device Class 1


Premarket Reviews
ManufacturerDecision
AMBU INTERNATIONAL A/S
  SUBSTANTIALLY EQUIVALENT 1
ENGINEERED MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
KING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 1
MARQUEST MEDICAL PRODUCTS INC
  SUBSTANTIALLY EQUIVALENT 1
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Crack 6
Break 2
Detachment of device component 2
Hole in material 1
Use of Device Issue 1
Total Device Problems 12

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 1 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Engineered Medical Systems,Inc I Apr-10-2013

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