Sodium Citrate Blood-pack Units, (pl 146 Plastic) Solution
FDA Label NDC 0942-9504

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fenwal, Inc. for the product Sodium Citrate Blood-pack Units, (pl 146 Plastic) (NDC 0942-9504). 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 package/label display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Package/Label Display Panel

CAUTION–DO NOT REMOVE UNIT FROM OVERWRAP UNTIL READY FOR USE
THE OVERWRAP IS A MOISTURE BARRIER
THE INNER BAG MAINTAINS STERILITY OF THE PRODUCT
STORE AT CONTROLLED ROOM TEMPERATURE.

CODE 4B7889Q

NDC 0942-9504-10

500 mL

Fenwal™

Anticoagulant Sodium Citrate Solution USP

Rx only

EACH 100 mL CONTAINS 4 g SODIUM CITRATE (DIHYDRATE) USP
pH ADJUSTED WITH CITRIC ACID

STERILE
NONPYROGENIC

FOR USE WITH CYTAPHERESIS DEVICE ONLY

NOT FOR DIRECT INTRAVENOUS INFUSION

SINGLE USE CONTAINER
DISCARD UNUSED PORTION

DO NOT USE UNLESS SOLUTION IS CLEAR AND NO LEAKS ARE DETECTED

AFTER REMOVING OVERWRAP CHECK FOR MINUTE LEAKS BY SQUEEZING INNER BAG FIRMLY
IF LEAKS ARE FOUND DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED

MANUFACTURED BY:
BAXTER HEALTHCARE CORPORATION
DEERFIELD, IL 60015 USA

MANUFACTURED FOR:

FENWAL, INC.
LAKE ZURICH, IL 60047 USA

MADE IN USA
07-25-58-000

PL 146 PLASTIC

Anticoagulant Sodium Citrate Solution Usp Label (Image 01)

Anticoagulant Sodium Citrate Solution Usp Label (Image 01)

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