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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mercy tape 2d and 3d models
Definition The Mercy TAPE device (2D and 3D models) is intended for use by health care professionals to estimate the body weight of pediatric patients between the ages of 2 months and 16 years, using linear measurements from specific anatomical landmarks made with the TAPE device for humeral length (HL, for the 2D model) or half-humeral length (HHL, for the 3D model) and the mid-upper arm circumference (MUAC).
Product CodePIR
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
CHILDREN'S MERCY HOSPITAL
  SUBSTANTIALLY EQUIVALENT 1

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