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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
Regulation Description Intravascular catheter.
Definition This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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
Regulation Number 880.5200
Device Class 2

Device Problems
Leak / Splash 1
Device Handling Problem 1
Loose or Intermittent Connection 1
Defective Device 1
Failure To Adhere Or Bond 1
Bent 1
Use of Device Problem 1
Total Device Problems 7

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical, Inc. II Feb-28-2018
2 Covidien LLC II May-31-2016
3 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Mar-09-2018
4 Windstone Medical Packaging, Inc. II Jun-01-2016

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