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510(k) Data Aggregation
(139 days)
BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology
The BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. 6F catheter is indicated for patients weighing >10 kg.
Maximum Power Injection Flow Rate:
- 6F Triple Lumen / 55 cm - 6 mL/sec
BioFlo PICC with ENDEXO and PASV Valve Technology
The BioFlo PICC with ENDEXO and PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. 6F catheter is indicated for patients weighing >10 kg.
Maximum Power Injection Flow Rate:
- 3F Single Lumen/55 cm - 1 mL/sec
- 4F Single Lumen/55 cm - 3.5 mL/sec
- 5F Single Lumen/55 cm - 5 mL/sec
- 5F Dual Lumen/55 cm - 4 mL/sec
- 6F Dual Lumen/55 cm - 5 mL/sec
- 6F Triple Lumen/55 cm - 6 mL/sec
BioFlo PICC with ENDEXO Technology
The BioFlo PICC with ENDEXO Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; for central venous pressure monitoring and for power injection of contrast media. 6F catheter is indicated for patients weighing >10 kg.
Maximum Power Injection Flow Rate:
- 3F Single Lumen/55 cm - 1 mL/sec
- 4F Single Lumen/55 cm - 3.5 mL/sec
- 5F Single Lumen/55 cm - 5 mL/sec
- 5F Dual Lumen/55 cm - 4 mL/sec
- 6F Dual Lumen/55 cm - 5 mL/sec
- 6F Triple Lumen/55 cm - 6 mL/sec
BioFlo Midline Catheter
The BioFlo Midline Catheter is indicated for short term access (< 30 days) to the peripheral venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and the sampling of blood and blood products.
Maximum Power Injection Flow Rate:
- 3F Single Lumen/20 cm - 2 mL/sec
- 4F Single Lumen/20 cm - 6 mL/sec
- 5F Single Lumen/20 cm - 6 mL/sec
- 5F Dual Lumen/20 cm - 6 mL/sec
Xcela Power Injectable PICC
The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. 6F catheter is indicated for patients weighing >10 kg.
Maximum Power Injection Flow Rate:
- 4F Single Lumen/45 cm - 4 mL/sec
- 4F Single Lumen/55 cm - 3.5 mL/sec
- 5F Single Lumen/55 cm - 5 mL/sec
- 5F Dual Lumen/45 cm - 5 mL/sec
- 5F Dual Lumen/55 cm - 4 mL/sec
- 6F Dual Lumen/55 cm - 5 mL/sec
Xcela PICC with PASV Valve Technology
The Xcela PICC with PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. 6F catheter is indicated for patients weighing >10 kg.
Xcela Hybrid PICC with PASV Technology
The Xcela Hybrid PICC with PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. 6F catheter is indicated for patients weighing >10 kg.
Maximum Power Injection Flow Rate:
- 6F Triple Lumen/55 cm - 6 mL/sec
The BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology is a radiopaque, polyurethane catheter with Luer lock hub(s), polyurethane extension tube(s) and suture wing capable of power injection that is available in a triple lumen configuration. The lumens are differentiated by colored Luer lock hubs that indicate lumen size, "No CT" for non-power injectable lumens are indicated on the luer lock hubs. For non-valved lumens, maximum power injection flow rates are indicated on the clamp(s).
The BioFlo PICCs with ENDEXO and PASV Valve Technology are radiopaque, polyurethane catheters with Luer lock hub(s), polyurethane extension tube(s) and suture wing capable of power injection. The catheter is available in single and multi-lumen configurations. The lumens are differentiated by colored Luer lock hubs that indicate lumen size and maximum power injection flow rates or "No CT" for nonpower injectable lumens.
The BioFlo PICC with ENDEXO Technology is a radiopaque, polyurethane catheter with luer lock hub(s), polyurethane extension tube(s) and suture wing. The catheter is available in single, dual and triple lumen configurations. The lumens are differentiated by colored clamps and hubs that indicate lumen size. Maximum power injection flow rates are indicated on the clamp(s).
The BioFlo Midline with ENDEXO Technology is a radiopaque, polyurethane catheter with luer lock hub(s), polyurethane extension tube(s) and suture wing. The catheter is available in single and dual lumen configurations. The BioFlo Midline is clearly labeled on all available catheter surfaces to identify as a MIDLINE versus a traditional PICC. Maximum power injection flow rates are indicated on the clamp(s). The catheter is offered in 3F, 4F, and 5F sizes.
The Xcela Hybrid PICC with PASV Valve Technology is a radiopaque, polyurethane catheter with Luer lock hub(s), polyurethane extension tube(s) and suture wing capable of power injection. The lumens are differentiated by colored Luer lock hubs that indicate lumen size. "No CT" for non-power injectable lumens are indicated on the luer lock hubs. For non-valved lumens, maximum power injection flow rates are indicated on the clamp(s).
The Xcela PICC with PASV Valve Technology is a radiopaque, polyurethane catheter with Luer lock hub(s), polyurethane extension tube(s) and suture wing capable of power injection. The catheter is available in single and multi-lumen configurations. The lumens are differentiated by colored Luer lock hubs that indicate lumen size and maximum power injection flow rates or "No CT" for non-power injectable lumens.
The Xcela Power Injectable PICC is a radiopaque, polyurethane catheter with Luer lock hub(s), polyurethane extension tube(s) and suture wing. The catheter is available in single and dual lumen configurations. The lumens are differentiated by colored clamps and hubs that indicate lumen size. Maximum power injection flow rates are indicated on the clamp(s).
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