Mercy Tape 2d And 3d Models
PIR is the FDA product code for Mercy Tape 2d And 3d Models, a class I device type, regulated under 21 CFR 878.4800. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PIR
- Device name
- Mercy Tape 2d And 3d Models
- FDA 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).
- Regulation
- 21 CFR 878.4800
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code PIR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2019 | 1 |
Applicants with the most clearances
Product code PIR| Applicant | Clearances |
|---|---|
| Children'S Mercy Hospital | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code PIR.
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