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

SODIUM CITRATE BLOOD-PACK UNITS, (PL 146 PLASTIC) — trisodium citrate dihydrate solution
Fenwal, Inc.

Anticoagulant Sodium Citrate Solution USP

A standalone direction insert does not exist for this product.

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
(click image for full-size original)
SODIUM CITRATE BLOOD-PACK UNITS, (PL 146 PLASTIC)
anticoagulant sodium citrate solution solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0942-9504
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRISODIUM CITRATE DIHYDRATE (Anhydrous Citric Acid) Anhydrous Citric Acid 4 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CITRIC ACID MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0942-9504-10 500 mL in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA BN770923 03/01/2007
Labeler — Fenwal, Inc. (794519020)
Registrant — Fenwal, Inc. (794519020)
Establishment
Name Address ID/FEI Operations
Baxter Healthcare Corporation 059140764 MANUFACTURE (0942-9504)

Revised: 02/2022 Fenwal, Inc.

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