PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


LABELS Bag 1 Anticoagulant Citrate Phosphate Dextrose Solution, USP; Bag 2 Additive Solution AS-1; Overwrap; Carton Anticoagulant Citrate Phosphate Dextrose Solution, USP - Bag 1 Label Additive Solution AS-1 - Bag 2 Label OVERWRAP LABEL CARTON LABEL

DESCRIPTION SECTION.


Description The Leucoflex CGP product consists of a blood collection system with 70ml of CPD for the collection of 50050ml of blood and 100ml of AS-1 Additive Solution. They are supplied with sterile, non-pyrogenic fluid pathways. The product as supplied includes an in-line leukocyte reduction filter known as Leucoflex CGP, storage containers for blood components and tubing, a sample diversion pouch (Bactivam), a vacuum tube adapter (Vacuvam), and a protective shield for the used needle (Secuvam). Representative Product Drawing

PRECAUTIONS SECTION.


CAUTIONS Do not fold or squeeze the Leucoflex CGP filter. Inappropriate handling may adversely affect filtration. Check for kinks in the tubing prior to collection and filtration. Rx only. The protective shield for needle Secuvam (A) and the vacuum tube adapter Vacuvam (B) features of the collection set aid in the safe collection of vacuum tube samples from the sample diversion pouch Bactivam (C) and the disposal of donor needles after blood collectin by providing protection from accidental needlestick. All or part of this medical device is made of PVC plasticized with DEHP. According to some studies, DEHP could potentially be harmful to the reproductive system of male fetuses. The prescriber is solely responsible for choosing to use this device on women who are either pregnant or breast-feeding, or on young male infants. Nevertheless, DEHP-plasticized PVC is in compliance with the European Pharmacopeia. All manufacturing processes and all components in contact with the donors, the users and the blood components dedicated to the patients are not made with natural rubber latex.

INSTRUCTIONS FOR USE SECTION.


HANDLING OF PORT PROTECTORS 1) Using both hands tear the port protector as indicated. (O) 2) Hold down the port protector pieces with one hand. (P) 3) Using the free hand, take the spike and engage intor the port. (Q) 4) Twist the spike to secure fully in port. (Q)

INTENDED USE OF THE DEVICE.


Intended Use The "Leucoflex CGP Leukocyte Reduction Filter" is intended for the leukocyte reduction of Red Blood Cells prepared from whole blood stored at 1-6C up to 24 hours after collection. The collection set provides for subsequent preparation of AS-1 Red Blood Cells, leukocytes Reduced (adenine saline added) and plasma in a closed system. The AS-1 Red Blood Cells, leukocytes Reduced and plasma may then be stored for the maximum allowable dating periods.

WARNINGS SECTION.


WARNING Avoid contact with sharp objects. DO NOT USE if the overwrap or blood bag system shows any signs of deterioration. DO NOT USE if the solutions are not clear. Dispose of all system components that have been contaminated with blood in a biohazard container as per your institution's SOP. Dispose of all sharps as per your institution's SOP.