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 W
| Device Type ID | 2843 |
| Device Name | Mercy Tape 2d And 3d Models |
| 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 |
| 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 Description | Manual Surgical Instrument For General Use. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General Hospital |
| 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) |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PIR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2843 |
| Device | Mercy Tape 2d And 3d Models |
| Product Code | PIR |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CHILDREN'S MERCY HOSPITAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |