a. BD Libertas™ Wearable Injector is a product in development; some statements are forward looking and are subject to a variety of risks and uncertainties. BD Libertas™ Wearable Injector is a device component intended for drug-device combination products and not subject to FDA 510(k) clearance or separate EU CE mark certification.
b. 2-5 mL or 5-10 mL.
C. 2-10 ml and upto 50a
1. Design Input Specification for BD Libertas™ Platform [Internal report]. Franklin Lakes, USA: Becton, Dickinson and Company; 2014. Revision: 08
a. 2-5 mL or 5-10 mL.
2. Tested using 19 cm (n=38); 23 cm (n=40); 28 cm (n=38); 33 cm (n=40) and 55 cm (n=39) tip-to-cuff length Pristine™ Long-Term Hemodialysis Catheters. Flow test performed using glycerin: water solution with a viscosity of 3.2-3.7 cP at 36-38° C. At an arterial maximum pressure of -250 mmHg or less, the maximum flow rates observed were 500 mL/min (19 cm through 33 cm tip-to-cuff lengths) and 379 mL/min (55 cm tip-to-cuff length). In order to show the flow rate at -250 mmHg pressure limit, the linear curve fit for the negative side was used to find the flow rate corresponding to indicated pressure, then the flow rate value was used to estimate the positive venous pressure. Bench data on file. Bench data may not necessarily correlate to clinical performance. Different test methods may yield different results.
3. Tested using 55 cm tip-to-cuff length Pristine™ Long-Term Hemodialysis Catheters (n=37). Recirculation test performed using 5% saline as blood simulant at a blood flow rate of ~5 liters/minute and catheter flow rate of 350 mL/min. The mean recirculation rates were 2.7% in forward flow and 2.8% in reverse flow. Bench data on file, Becton, Dickinson and Company, Tempe, AZ. Bench data may not necessarily correlate to clinical performance. Different test methods may yield different results.
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