Pharmaseal Dual Lumen Catheter

FDA-Cleared Indications

• Central venous access for administration of medications and fluids.
• Central venous access for hemodynamic monitoring.
• Use when dual-lumen venous access is clinically beneficial.

Clinical Applications

• Administration of intravenous medications through central venous access.
• Administration of intravenous fluids through central venous access.
• Hemodynamic monitoring, including central venous pressure monitoring, when clinically indicated.
• Simultaneous venous access for different therapies using the catheter's separate lumens.

Reported off-label uses

• Use as temporary venous access during some interventional procedures when the catheter's specifications and institutional protocols permit.
• Administration of therapies not specifically described in the available labeling, when directed by a qualified clinician.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• Select the catheter size and length based on the patient's anatomy, the intended access vein, and the required flow or monitoring function.
• Insertion should use an appropriate central venous access technique with sterile or aseptic precautions to reduce infection and other complications.
• Confirm compatibility with the infusion solutions, monitoring equipment, guidewires, introducers, and other components used in the procedure.
• The available record does not establish MRI safety, MRI conditional labeling, or the catheter's exact size range; verify the original instructions for use before MRI or device selection.
• Evaluate for patient-specific risks and contraindications to central venous catheterization, including infection at the access site, thrombosis, bleeding risk, or unsuitable venous anatomy.