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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device i.v. start kit
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeLRS
Device Class Not Classified


Premarket Reviews
ManufacturerDecision
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
FERRIS MFG. CORP.
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1
HOSPIRA INC.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
TRINITY
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1

Device Problems
Device operates differently than expected 2
Foreign material present in device 1
Material integrity issue 1
No Known Device Problem 1
Device handling issue 1
Failure to Adhere or Bond 1
Bent 1
Use of Device Issue 1
Defective item 1
Total Device Problems 10

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 1 0 1 0 0 0 0 0
Class II 0 0 0 0 5 0 0 0 0 2
Class III 0 0 0 0 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products II Feb-09-2011
2 Centurion Medical Products II Feb-01-2011
3 Centurion Medical Products Corporation II May-27-2011
4 Centurion Medical Products Corporation I Mar-08-2011
5 Churchill Medical Systems, Inc. II Aug-22-2011
6 Covidien LLC II May-31-2016
7 Covidien LLC III May-11-2013
8 Neo Medical, Inc. II May-19-2011
9 Tri-State Hospital Supply Corporation I Mar-25-2009
10 Windstone Medical Packaging, Inc. II Jun-01-2016

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