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U.S. Department of Health and Human Services

Product Classification

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Device mercy tape 2d and 3d models
Regulation Description Manual surgical instrument for general use.
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).
Physical State The Mercy TAPE device consists of semi-durable or disposable flexible strips of coated paper, fabric or plastic tape printed with numbered bins proportional to fractional body weight of pediatric patients.
Technical Method The 2D and 3D Mercy TAPE device combines the physical properties of the simple tape measure, with the intended use of the Stand-on patient scale and patient scale, which is estimation of body weight. TAPE performs this function based on an algorithm that is unique to the Mercy TAPE device. TAPE uses linear anthropometric body measurements to derive estimated body weight.
Target Area for humeral length (HL, for the 2D model) or half-humeral length (HHL, for the 3D model) and the mid-upper arm circumference (MUAC).
Regulation Medical Specialty General & Plastic Surgery
Review Panel General Hospital
Product CodePIR
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 878.4800
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible