FDA Label for Sodium Citrate Blood-pack Units, (pl 146 Plastic)
View Indications, Usage & Precautions
Sodium Citrate Blood-pack Units, (pl 146 Plastic) Product Label
The following document was submitted to the FDA by the labeler of this product Fenwal, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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