Blood Collecting Needle 3 Indications for Use/Target Users 1.1 The blood collecting needle is a single-use, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a non-invasive device to collect blood or plasma. 5.1 Handle with care to avoid needle sticks. 5.2 Do not replace original needle cover after use. 5.3 Use once and discard immediately in accordance with local safety standards. 5.4 If needle is bent or damaged, no attempt should be made to straighten needle or use the product. 5.6 Do not reuse. Reuse of needle can result in contamination or transmit disease. 6.1 There are no recognized contraindications for the use of blood collecting needles. 7.1 Blood collecting Needles are sterilized by Ethylene Oxide (EtO) gas sterilization (indicated by STEfflHE°) single use only. 7.4 Inspect each package prior to use. 7.5 Do not use the component if any seal or cavity is damaged ® or breached or if the expiration date has been exceeded. Once opened the device must be used or discarded. 2.1 The blood collecting needle is intended to collect blood or plasma from the patient. 3.1 Blood collecting needles are equipped with a male Luer/Luer lock connector that can be used in conjunction with syringes and infusion/transfusion sets. 3.2 The device is designed for use by a qualified physician or clinician. 3.3 Blood collecting needles are indicated for use with the general patient population. 4.2 Sharp, stainless-steel needle 4.3 Rapid delivery of fluids 4.4 Prevent cross-contamination between patients. 4.5 Each needle is individually packaged, sterilized and ready for use. 8.1 Hold cap/sheath and twist to separate and break off tamper proof seal. 8.3 While holding sheath firmly, thread needle securely into clear luer holder. 8.4 Push empty vacuum tube up to the guide line. inside the luer holder. 8.5 Remove the sheath and perform the venipuncture procedure according to established technique, pushing the vacuum tube the rest of the way into the luer holder. 8.6 For multiple samples, vacuum tubes can be subsequently inserted by using the standard tube changing technique. 8.7 After the procedure, discard of the needle in a biohazard container according to local safety standards.

9 Storage 9.1 Store at room temperature 15°C-25°C. 9.2 Do not store in high temperatures and humidity. 9.3 Keep away from direct sunlight. 9.4 Store in a cool and dry place. Graphic Symbol Legend for Medical Device Labeling Medical Device Catalog number Federal law (USA) restricts this device to sale by or on the order of a physician. LEGAL NOTICE © 2024 Exelint International, Co. All rights reserved. EXEL and the EXEL logo are trademarks of EXELINT International, Co. EXELINT International, Co. disclaims any responsibility for possible consequences resulting from reuse, resterilization or improper...