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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device first aid kit with drug
Definition Note: In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well. www.fda.gov/cder/index.html - 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 CodeLRR
Device Class Not Classified


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1

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

Recalls
Manufacturer Recall Class Date Posted
1 First Aid Only Inc III Feb-19-2008
2 Lifeline First Aid LLC II Oct-27-2011
3 Lighthouse For The Blind III Apr-10-2013

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