Syringe,disp,20ml,ster/BOX-80

General Description:
Syringe, 20ml, sterile, Luer, disposable, box of 80

Intended use: inject fluids into, or withdraw fluids from, the body

Technical specifications:
Syringe Components: Syringe, two pieces: barrel with Luer nozzle and piston/plunger or three pieces: barrel with luer nozzle, stopper and piston/plunger.
Syringe capacity: 20ml
Syringe graduation: Graduated scale on the barrel, easy to read. Scale intervals of 2.0 ml. Graduation lines of 5.0 ml or 10.0 volume increment conform to ISO 7886-1:2017.
Syringe Barrel: sufficiently transparent to allow easy measurement of the volume contained in the syringe and detection of air bubbles. Length with a maximum usable capacity of at least 10% more than the nominal capacity conform to ISO 7886-1:2017.
Barrel Nozzle: Luer lock or luer slip in accordance with ISO 80369-7:2021. Luer nozzle is centric or acentric.
Syringe Material: medical grade plastic (Polyethylene (PE)/ polypropylene (PP)/ polystyrene (PS).
Disposable.
Sterile, (ethylene oxide sterilization and compiles to ISO 11135:2019)

Standards:
Product and packaging conform to ISO 7886-1:2017, ISO 11135:2019.
Quality management system (QMS): Products and manufacturer must be certified and comply with ISO 13485: 2016 requirements (or equivalent).
Marketing approval certificate: Product and manufacturer must conform to European Medical Device Regulation (EU) 2017/745 (or equivalent).

Packaging and labelling:
Primary packaging: Unit of use.
1 syringe packed in an individual sterilized peel-pack made of paper and/or plastic.

Secondary packaging: Protected unit.
1 box of 80 blister packed syringes.

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