Anticoagulant Sodium Citrate Solution, Usp
Sterile, non-pyrogenic fluid path. Sterilized by steam.
Rx only.
250 ml volume bag.
Store at room temperature.
Anticoagulant Sodium Citrate
FDA Label NDC 62646-798
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medsep Corporation for the product Anticoagulant Sodium Citrate (NDC 62646-798). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding anticoagulant sodium citrate solution, usp, indications and usage, warnings, general precautions, how supplied, information for patients, container text displayed, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications And Usage
For use with automated plasmapheresis equipment only. Use according to equipment manufacturer’s instructions. This unit should be used for plasmapheresis only.
Warnings
Not for direct intravenous infusion.
DO NOT VENT.
Avoid excessive heat. Protect from freezing.
General Precautions
Do not use unless solution is clear and no leaks are detected.
Discard unused portion.
How Supplied
Single Use Container.
Information For Patients
Medsep Corporation, A Subsidiary of Pall Corp., Covina, CA 91722, USA
Visit us at www.pall.com/medical
For Pall customer service, call: 1.800.645.6578
Container Text Displayed
Sodium Citrate Bag Text (143798603bag)
ANTICOAGULANT SODIUM CITRATE SOLUTION, USP
250 mL Code 798-60
For use with automated plasmapheresis equipment only. Each 250 mL of anticoagulant contains 10.0 g sodium citrate (dihydrate), USP (pH adjusted with citric acid, USP).
CAUTION: Not for direct intravenous infusion.
Do not use unless anticoagulant is clear. This unit should be used for plasmapheresis only. Sterile, nonpyrogenic fluid path. Sterilized by steam. Rx Only.
DO NOT VENT.
Package Label.Principal Display Panel
Issued August 2010, 147798603
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