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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device unit, liquid-oxygen, portable
Regulation Description Portable liquid oxygen unit.
Product CodeBYJ
Regulation Number 868.5655
Device Class 2


Premarket Reviews
ManufacturerDecision
CAIRE
  SUBSTANTIALLY EQUIVALENT 3
HOGAN & HARTSON L.L.P.
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
MINNESOTA VALLEY ENGINEERING, INC.
  SUBSTANTIALLY EQUIVALENT 4
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 7
PENOX TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
PRECISION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
THE JOHN BUNN CO.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 24
No code available 2
Output, low 1
Use of Device Issue 1
Replace 1
Inadequate service 1
Improper or incorrect procedure or method 1
Medical Gas Supply problem 1
Decrease in pressure 1
Reflux within device 1
Out-of-box failure 1
Free or unrestricted flow 1
Filling problem 1
Improper flow or infusion 1
No Information 1
Total Device Problems 39

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 0 1 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Caire, Inc. II Aug-26-2008

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