Introducing MedGeneRx® HP 15 PRP - FDA-Cleared for Sale
PRP Kit Specifications 15mL Protocol
- FDA-Cleared, Class II Medical Device, 510(k)-Cleared
- Integrated anticoagulant- No ACD-A needed
- Industry leader in three critical areas:
Reproducible concentrations from consistent platelet recovery/85+%
Balanced pH
99% removal of RBCs
- Vacutainer system for simplified blood collectionical Device, 510(k)-Cleared
- Compatible with existing 30mm diameter centrifuges
- Single spin 15mL’s of whole blood
3mL’s high concentration PRP
5mL’s mid concentration PRP
Platelet-Rich Plasma (PRP Kit) Description
MedGeneRx® HP 15 PRP Kit is FDA-Cleared and indicated for the rapid preparation of autologous Platelet Rich Plasma (PRP) from a small sample of blood at the patient’s point -of-care.
SKU: ZG-PRP-HP15
MedGeneRx® HP 15 PRP Optional Accessory Kit:
- Single 10mL Luer Syringe
- Single 3mL Luer Syringe
- 21g Butterfly safety needle and vacutainer holder
- Additional vacutainer transfer holder
- Single 30g 1/2" needle
- Single male-to-male Luer-Lok syringe transfer connector
- Single tourniquet
- Single Band-aid (standard size)
- One 2x2 gauze packet
- Single alcohol pad
MedGeneRx® HP 15 PRP Kit is FDA-Cleared and indicated for the rapid preparation of autologous Platelet Rich Plasma (PRP) from a small sample of blood at the patient’s point -of-care.
SKU: ZG-PRP-HP15
MedGeneRx® HP 15 PRP Optional Accessory Kit:
(1) MedGeneRx® HP 15 Vacutainer
(2) 10cc Syringes
(1) 21g Butterfly Needle
(1) 3 inch 19g Spinal Needle
510(k) equivalence study conducted and the following mean results were achieved:
- Platelet Concentration Factor at 0 Hours = 4.1 – 4.5x baseline
- Platelet Concentration Factor at 1 Hour = 4.5 – 4.8x baseline
- Platelet Recovery % at 1 Hour = 61%
- RBC at 0 Hours = 0.01
- RBC at 4 Hours = 0.01
- pH at 0 Hours = 7.5
- pH at 4 Hours = 7.65
- Platelet Activation (Resting) at 0 Hours = 10.2%
- Platelet Activation (Stimulated ADP) at 0 Hours = 96.3%
- Platelet Aggregation at 0 Hours = 96.1%
- Platelet Aggregation at 4 Hours = 95.8%
- HCT at 0 Hours = 0.01%
- HCT at 4 Hours = 0.01%
- WBC at 0 Hours = 0.6
- WBC at 4 Hours = 0.6
510(k) equivalence study conducted and the following mean results were achieved:
• Platelet Concentration Factor at 0 hours = 3.8-4.1x baseline
• Platelet Concentration Factor at 1 Hour = 4.1-4.3 x baseline
• Platelet Recovery % at 1 hours = 53%
• RBC at 0 hours- 0.1
• RBC at 4 hours- 0.01
• pH at 0 hours = 7.59
• pH at 4 Hours = 7.69
• Platelet Activation resting at 0 hours= 9.7%
• Platelet Activation stimulated ADP 0 hours = 95.1%
• Platelet Aggregation at 0 hours = 95.1%
• Platelet Aggregation at 4 Hours = 94.8%
• HCT at 0 hours = 0.0 %
• HCT at 4 Hours = 0.0%
• WBC at 0 hours= 0.3
• WBC at 4 hours= 0.3
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