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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device attachment, breathing, positive end expiratory pressure
Regulation Description Positive end expiratory pressure breathing attachment.
Product CodeBYE
Regulation Number 868.5965
Device Class 2


Premarket Reviews
ManufacturerDecision
AMBU INTERNATIONAL A/S
  SUBSTANTIALLY EQUIVALENT 2
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
ENGINEERED MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
GALEMED CORP.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT - KIT 1
LIFE SUPPORT PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 1
MERCURY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 6
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
SIMS
  SUBSTANTIALLY EQUIVALENT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 6
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Misassembled 2
Blocked connection 2
Device misassembled during manufacturing or shipping 2
Pressure issue 1
Deployment issue 1
Disconnection 1
Gradient increase 1
Total Device Problems 10

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

Recalls
Manufacturer Recall Class Date Posted
1 Airways Development LLC II Dec-24-2015
2 Ambu Incorporated II Dec-22-2007
3 Smiths Medical ASD, Inc. II Jul-16-2008

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