Definition: Preparation Of Autologous Platelet Rich Plasma Gel From A Small Sample Of Peripheral Blood For Wound Management.
| Device Type ID | 2448 |
| Device Name | Peripheral Blood Processing Device For Wound Management |
| Physical State | May Include Centrifuge And Sterile Single-use Tubes And Disposables |
| Technical Method | Uses Centrifugal Methods To Separate Whole Blood Into Components, After Which The Platelet Rich Plasma Gel Is Withdrawn |
| Target Area | Blood Drawn From Peripheral Veins, PRP Gel Topically Applied To Exuding Cutaneous Wounds Such As Leg Ulcers, Pressure Ulcers And Diabetic Ulcers, And Mechanically Or Surgically-debrided Wounds |
| Regulation Description | Automated Blood Cell Separator. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.9245 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PMQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |