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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device collector, urine, (and accessories) for indwelling catheter
Regulation Description Urine collector and accessories.
Product CodeKNX
Regulation Number 876.5250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BEIERSDORF
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BRISTOL-MYERS SQUIBB
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 5
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOLLISTER, INC.
  SUBSTANTIALLY EQUIVALENT 4
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 12
MAERSK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 4
NEOTECH PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
POST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAGE PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SIMPORT PLASTICS LTD
  SUBSTANTIALLY EQUIVALENT 1
SNYDER LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELCON, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Blockage within device or device component 6
Tear, rip or hole in device packaging 2
No Known Device Problem 1
Material separation 1
Device damaged prior to use 1
Total Device Problems 11

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

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LP II May-27-2011

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