Sodium Citrate Blood-pack Units, (pl 146 Plastic) Solution
FDA Label NDC 0942-9505

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 0942-9505). 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

Fenwal™

Anticoagulant Sodium Citrate Solution USP

Rx only

CODE 4B7867Q

NDC 0942-9505-10

250 mL

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

PL 146 PLASTIC

MANUFACTURED BY:
BAXTER HEALTHCARE CORPORATION
DEERFIELD, IL 60015 USA

MANUFACTURED FOR:

Logo (Image 01)

Logo (Image 01)

FENWAL, INC.
LAKE ZURICH, IL 60047 USA

MADE IN USA

07-25-02-996 REV: C

Anticoagulant Sodium Citrate Solution Usp Label (Image 02)

Anticoagulant Sodium Citrate Solution Usp Label (Image 02)

* Please review the disclaimer below.