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FDA Drug information

Sodium Citrate Blood-Pack Units, (PL 146 Plastic)

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Description

Anticoagulant Sodium Citrate Solution USP A standalone direction insert does not exist for this product.

Effective Time

20220211

Version

5

Spl Product Data Elements

Sodium Citrate Blood-Pack Units, (PL 146 Plastic) Anticoagulant Sodium Citrate Solution TRISODIUM CITRATE DIHYDRATE Anhydrous Citric Acid WATER CITRIC ACID MONOHYDRATE

Application Number

BN770923

Brand Name

Sodium Citrate Blood-Pack Units, (PL 146 Plastic)

Generic Name

Anticoagulant Sodium Citrate Solution

Product Ndc

0942-9505

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

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: FENWAL, INC. LAKE ZURICH, IL 60047 USA MADE IN USA 07-25-02-996 REV: C logo Anticoagulant Sodium Citrate Solution USP label

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