HZ 1485480-1

Quality Procedure Scope

B019004 - BLOOD COMPONENTS SAMPLING BAGS AND KITS C900103 - PERCUTANEOUS ARTERIAL ACCESS HAEMOSTASIS SYSTEMS The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions

Quality Procedure Scope

A010101 - HYPODERMIC NEEDLES A020102 - INFUSION AND IRRIGATION SYRINGES, SINGLE-USE C010101 - PERIPHERAL I.V. CATHETERS C030101 - EXTRACORPOREAL CIRCULATION KITS Z121799 - BLOOD TRANSFUSION INSTRUMENTS - OTHER A010102 - BUTTERFLY NEEDLES A019099 - NEEDLES FOR OTHER PROCEDURES - OTHER G0399 - DIGESTIVE ENDOSCOPY DEVICES - OTHER C040201 - PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES C040202 - PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES C0504 - ARTERIAL INTRODUCTION SETS A020199 - SYRINGES, SINGLE-USE - OTHER C010402 - PERIPHERAL ANGIOGRAPHY DEVICES B020101 - BED-SIDE LEUKOREDUCTION FILTERS V010402 - LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE

Quality Procedure Scope

B010202 - BLOOD TRANSFER BAGS AND KITS PLATELETS CONCENTRATE TRANSFER BAGS AND KITS Intended Purpose: TERUFLEX BP-KIT with IMUGARD III-SPL is intended for pooling up to six buffy-coats, for in process filtration and preservation of leukocyte removed platelet concentrate. B010202 - BLOOD TRANSFER BAGS AND KITS PLATELETS CONCENTRATE TRANSFER BAGS AND KITS Intended Purpose: TERUFLEX BP-KIT is intended for pooling up to six buffy-coats, for in process separation and preservation of platelet concentrates. B010201 - BLOOD TRANSFER BAGS AND KITS WHOLE BLOOD, RED BLOOD CELLS OR PLASMA TRANSFER BAGS AND KITS Intended Purpose: TERUFLEX TRANSFER BAG is intended for separating and storing each blood component. Z120303 - INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS INFUSION INSTRUMENTS Intended Purpose: TERUFUSION TE-18 is an infusion pump intended for the controlled delivery of parenteral nutrition, fluid maintenance, which is conducted by healthcare professionals, in a clinical environment. B020102 – LEUKOREDUCTION FILTERS LABORATORY LEUKOREDUCTION FILTERS Intended Purpose: IMUGARD III-RC is intended for the removal of leukocytes from a single unit of packed red blood cells or whole blood.

Quality Procedure Scope

C010401 - ANGIOGRAPHY AND HAEMODYNAMIC DEVICES CARDIAC ANGIOGRAPHY DEVICES Intended Purpose: Use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site. C0504 - CARDIOVASCULAR INTRODUCER SHEATHS ARTERIAL INTRODUCTION SETS Intended Purpose: The device is intended to be inserted percutaneously into a vessel to facilitate the insertion of angiographic, electrode, balloon, or similar catheters. C0499 - CARDIOVASCULAR GUIDEWIRES CARDIOVASCULAR GUIDEWIRES – OTHER Intended Purpose: The device is intended to direct a catheter to the desired anatomical location in the vascular system during diagnostic or interventional procedures.