SODIUM CITRATE BLOOD-PACK UNITS, (PL 146 PLASTIC) - anticoagulant sodium citrate solution solution 
Fenwal, Inc.

----------

Anticoagulant Sodium Citrate Solution USP

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
SODIUM CITRATE BLOOD-PACK UNITS, (PL 146 PLASTIC) 
anticoagulant sodium citrate solution solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0942-9504
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0942-9504-10500 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDABN77092303/01/2007
Labeler - Fenwal, Inc. (794519020)
Registrant - Fenwal, Inc. (794519020)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Healthcare Corporation059140764MANUFACTURE(0942-9504)

Revised: 2/2022
Document Id: f2b75651-90cf-4982-9762-76db5f0524d1
Set id: ac8971a9-36d0-43c9-9121-ba5e58c28bed
Version: 5
Effective Time: 20220211
 
Fenwal, Inc.