Intended purpose of use: inject fluids into, of withdraw fluids from, the body.
Product description: Syringe, two pieces: barrel with Luer nozzle and piston/plunger of three pieces: barrel with luer nozzle, stopper and piston/plunger. Preferably with retractable needle to prevent reuse and needle stick injury.
Capacity: 5ml.
BARREL with finger tip: Materials: medical grade PE (polyethylene) of PP (polypropylene); transparent for easy reading and for detecting air bubbles. Graduated scale on the barrel, easy to read, with scale interval of 0.2 and 1.0ml increment between graduation lines to be numbered.
Concentric luer nozzle for 5ml capacity.
piston : Medical grade polypropylene, polyethylene, fit to slide easily and smoothly inside the barrel.
needle: 21G (0.80 x 38-40 mm) , stainless steel, tapered bevel, lubricated, with protective cap.
HUB : plastic medical grade, colour coded as per ISO 6009 , green for 21G (0.80 x 40 mm).
SAFETY MECHANISM, if offered : Integrated and retractable, Needle retracts automatically into the barrel upon administration of full dose. WHO PQ'ed as per Category E013 Hypodermic syringe with reuse prevention feature (RUP).
stopper (for 3-piece syringe): Material is elastomer, medical grade, Located at the end of the plunger, Ensures a secure and safe seal.
Sterile and disposable.
Sterilization method: ethylene oxide.
Shelf life 5 years.
Instructions for use as per the item features offered:
Injection safety:
The syringe is sterile, ready for immediate use and is for single use ONLY.
Check the integrity of the packaging before opening.
Do not use the syringe if the packaging is not sealed of is pierced.
Disposal instructions such as "NEVER recap the needle after use and IMMEDIATELY dispose of the mounted syringe and needle into a puncture-proof safety container", as applicable to the item offered.
Supplied with:
Manufacturer's instruction for use, indications for use, contraindications, warnings, precautions for use, storage conditions, disposal instructions etc shall be provided.
Packaging and labelling as per regulations applied to the device:
Primary packaging: each syringe and needle bi-packed in an individual sterilized peel-off pack made of paper and/of plastic.
Secondary packaging: Protective packaging - 1 carton of 100 bi-packed syringes with needles.
Labelling same as per primary packaging.
Symbols used according ISO 15223.
CE Mark with Notified Body number.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance.
CE certificate available for Class IIa and above devices.
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016.
Classification:
Classified under EU MDR 2017/745 as Class Is device.
Product description: Syringe, two pieces: barrel with Luer nozzle and piston/plunger of three pieces: barrel with luer nozzle, stopper and piston/plunger. Preferably with retractable needle to prevent reuse and needle stick injury.
Capacity: 5ml.
BARREL with finger tip: Materials: medical grade PE (polyethylene) of PP (polypropylene); transparent for easy reading and for detecting air bubbles. Graduated scale on the barrel, easy to read, with scale interval of 0.2 and 1.0ml increment between graduation lines to be numbered.
Concentric luer nozzle for 5ml capacity.
piston : Medical grade polypropylene, polyethylene, fit to slide easily and smoothly inside the barrel.
needle: 21G (0.80 x 38-40 mm) , stainless steel, tapered bevel, lubricated, with protective cap.
HUB : plastic medical grade, colour coded as per ISO 6009 , green for 21G (0.80 x 40 mm).
SAFETY MECHANISM, if offered : Integrated and retractable, Needle retracts automatically into the barrel upon administration of full dose. WHO PQ'ed as per Category E013 Hypodermic syringe with reuse prevention feature (RUP).
stopper (for 3-piece syringe): Material is elastomer, medical grade, Located at the end of the plunger, Ensures a secure and safe seal.
Sterile and disposable.
Sterilization method: ethylene oxide.
Shelf life 5 years.
Instructions for use as per the item features offered:
Injection safety:
The syringe is sterile, ready for immediate use and is for single use ONLY.
Check the integrity of the packaging before opening.
Do not use the syringe if the packaging is not sealed of is pierced.
Disposal instructions such as "NEVER recap the needle after use and IMMEDIATELY dispose of the mounted syringe and needle into a puncture-proof safety container", as applicable to the item offered.
Supplied with:
Manufacturer's instruction for use, indications for use, contraindications, warnings, precautions for use, storage conditions, disposal instructions etc shall be provided.
Packaging and labelling as per regulations applied to the device:
Primary packaging: each syringe and needle bi-packed in an individual sterilized peel-off pack made of paper and/of plastic.
Secondary packaging: Protective packaging - 1 carton of 100 bi-packed syringes with needles.
Labelling same as per primary packaging.
Symbols used according ISO 15223.
CE Mark with Notified Body number.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance.
CE certificate available for Class IIa and above devices.
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016.
Classification:
Classified under EU MDR 2017/745 as Class Is device.
| Pack Size | Avg. Price |
|---|---|
| Pack of 100 | $3.36 |
