# Mercy Tape 2d And 3d Models
> **Product code: PIR** · Class I — Low Risk (general controls) · General, Plastic Surgery · 21 CFR 878.4800
## Classification
- **FDA Product Code:** PIR
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 878.4800
- **Review panel:** HO
- **Medical specialty:** General, Plastic Surgery
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## 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).

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PIR)
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