1. MODELS
LUER SLIP SYRINGES WITH NEEDLE

2. Dead Space :

3. CERTIFICATION

4. COMPONENTS AND MATERIALS

4.1 Materials of Concern
Materials of concern are chemicals or substances that have been identified as having the potential to cause long term effects on humans or the environment.

4.2 Biocompatibility
Mumu products comply with the requirements of the standard for biocompatibility of medical devices, ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing.

5. SHELF LIFE
Shelf life : 3 years after sterilization
Sterile syringe (with needle) has to be stored between 5~ 30° C temperature.
The device has to be stored in a clean, cool, dry and dark place to protected from sunlight and moisture. The products should be stored in such a way that the integrity of the packages (boxes) is maintained.

6. STANDARDS

6.1. Classification
Class IIa Medical Device under Rule 2, Annex IX of Directive 93/42/EEC as amended by Directive 2007/47/EC.

6.2. GMDN Code
GMDN code 47017: General purpose syringes.

6.3. Good Manufacturing Practices
The entire manufacturing and testing processes follows
Good Manufacturing Practices as specified below.

» Incoming raw materials are verified via material inspection and testing and our suppliers are approved via our vendor management system.
» In addition to the automatic on-line inspections, in-process inspections are performed in addition to final product testing to ensure compliance with approved specifications.
» The manufacturing and testing details of each batch of product are recorded on a batch record which is retained in accordance with our document control procedures

7. INSTRUCTION FOR USE

i. Remove the needle cap. Do not touch the needle or set the syringe down while the cap is off.
ii. Pull air into the syringe equal to the amount of medicine to be given.
iii. Push the needle through the top of the bottle at a 90 degree angle. Push the plunger to transfer the air into the bottle.
iv. Turn the bottle upside down. Gently pull the plunger to fill the syringe with the amount of medicine to be administered.

v. If there is a bubble in the syringe, draw up an additonal small volume of the medicine. Tap the side of the syringe to make the air bubbles go to the top. Push the plunger to get the air out of the syringe.
vi. Check the syringe to make sure the dosage is correct.

vii. Once the medicine is in the syringe, place the needle cap on a flat surface. Remove the needle from the bottle. Using one hand, slowly guide the needle into the cap. Do not touch the needle.
viii. Lift syringe and snap on needle cap.
ix. Clean the skin at the injection site with an alcohol swab. Allow site to dry. Hold the syringe barrel like a pencil and remove the cap. With your thumb, pull the skin back away from the spot where you are going to inject the medication. Hold the skin off to the side about 2,5-3 cm. Insert the needle quickly at a 90 ° angle.

x. After slowly pushing the plunger all the way in, remove the needle from the skin. Release your tumb that has been holding back the skin.
xi. Do not put the cap back on the used needle. Place the used needle any syringe into a sharps box or hard plastic medical waste container. Hold a gauze pad or dry tissue over the injection site for a few seconds if needed.

8. PACKAGING

8.1 Packaging Material
LABELS: according to European Medical Device directive.

8.2 Labelling