Description
Re-Order Product Code: 798-60
250 mL volume. Single use container.
Sterile, nonpyrogenic fluid path. Sterilized by steam.
Store at room temperature.
Sodium Citrate
FDA Label NDC 53157-798
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Haemonetics Manufacturing Inc for the product Sodium Citrate (NDC 53157-798). 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 description, indications and usage, contraindications, warnings, precautions, general, how supplied, 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.
Contraindications
Not for direct intravenous infusion.
Warnings
Avoid excessive heat. Protect from freezing. Do NOT vent.
Precautions
Do not use unless solution is clear and no leaks detected.
General
Rx only. Discard unused portion.
Recommended Storage: Store at room temperature (25°C / 77°F).
How Supplied
250 mL volume bag.
Each 250 ml contains:
10.0 g sodium citrate (dihydrate), USP
Package/Label Principal Display Panel
Bag Label
Envelope Label
References
HAEMONETICS and THE Blood Management Company are trademarks of Haemonetics Corporation.
Manufactured for:
Haemonetics Corporation
400 Wood Road
Braintree, MA 02184, USA
By: Haemonetics Manufacturing Inc.
1630 Industrial Park Street
Covina, CA 91722, USA
* Please review the disclaimer below.
