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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mask, oxygen
Regulation Description Oxygen mask.
Product CodeBYG
Regulation Number 868.5580
Device Class 1


Premarket Reviews
ManufacturerDecision
B & F MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
LIFE SUPPORT PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INDUSTRIES AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 2
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WESTMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Normal 2
Occlusion within device 1
Other (for use when an appropriate device code cannot be identified) 1
Detachment of device component 1
Total Device Problems 5

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 5 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Convatec Inc. II Feb-15-2011
2 King Systems Corp. II Apr-06-2011
3 Salter Laboratories, Division of Regulatory Affairs II Oct-26-2011
4 Smiths Medical II Jun-24-2011
5 Vital Signs Devices, a GE Healthcare Company II Jun-29-2011

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