Leukotrap – CP2D Solution (Page 2 of 2)

MANUFACTURER

Manufactured for: Haemonetics Corporation

400 Wood Road

Braintree, MA 02184, USA

By: Haemonetics Manufacturing Inc.

1630 Industrial Park Street

Covina, CA 91722, USA

Visit us at www.haemonetics.com

Phone: 888-489-5938

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL

Leukotrap® RC System

CP2D/AS-3 Triple Blood Bag Unit with In-Line RCM1 and ATS-LPL Filters and Sample Diversion Pouch

For collection of 500 ml of blood and preparation of red blood cells, plasma or platelets with pre-storage leukocyte reduction of red blood cells.

Each unit consists of a collection bag with 70 ml of CP2D solution, an additive bag with 110 ml of AS-3 solution, and two empty CLX® satellite bags. Each 70 ml of CP2D solution contains 3.57 g dextrose (monohydrate), USP; 1.84 g sodium citrate (dihydrate), USP; 0.229 g citric acid (monohydrate), USP; and 0.155 g monobasic sodium phosphate (monohydrate), USP. Each 110 ml of AS-3 solution contains 1.21 g dextrose (monohydrate), USP; 0.647 g sodium citrate (dihydrate), USP; 0.451 g sodium chloride, USP; 0.304 g monobasic sodium phosphate (monohydrate), USP; 0.046 g citric acid (monohydrate), USP; and 0.033 g adenine, USP.

Sterile, nonpyrogenic fluid path. Sterilized by steam. See accompanying directions for use. Rx only. Store at room temperature. Unused bags in opened pouches may be kept 30 days by folding and SECURING open end of pouch to prevent possible loss of moisture.

3 Units

Code 123-93

LEUKOTRAP — CP2D SOLUTION anticoagulant citrate phosphate double dextrose solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53157-123 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROSE (DEXTROSE) DEXTROSE 3.57 g in 70 mL

Product Characteristics Color yellow (anticoagulant) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:53157-123-01 6 BAG in 1 POUCH contains a BAG (53157-123-00) 1 NDC:53157-123-00 70 mL in 1 BAG This package is contained within the POUCH (53157-123-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA BN820915 11/09/1983

LEUKOTRAP — AS-3 SOLUTION additive solution — 3 solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53157-124 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROSE (DEXTROSE) DEXTROSE 1.21 g in 110 mL ADENINE (ADENINE) ADENINE 0.033 g in 110 mL

Product Characteristics Color yellow (additive) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:53157-124-01 6 BAG in 1 POUCH contains a BAG (53157-124-00) 1 NDC:53157-124-00 110 mL in 1 BAG This package is contained within the POUCH (53157-124-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA BN820915 11/09/1983

Labeler — Haemonetics Corporation (057827420)

Establishment
Name	Address	ID/FEI	Operations
Haemonetics Manufacturing Inc		078598396	manufacture (53157-123), manufacture (53157-124)

Revised: 01/2020 Haemonetics Corporation