Intended purpose of use: For accurate administration of low volume injections such as Vitamin K for newborns and infants
Product Description:
Syringe (0.5ml) preaffixed permanently to a needle with a protective cap
Sterile, single use, disposable.
Sterilization method: ethylene oxide of gamma radiation.
Non-toxic. Pyrogen free.
Colour code: visible at the base of the needle and complies with ISO 6009
Shelf life 5 yrs
Syringe:
Capacity: 0.5 ml.
Graduated scale on the barrel with 0.01 ml (minor) and 0.1 ml (major) increment lines.
Barrel sufficiently transparent to allow easy measurement of the volume contained in the syringe and detection of air bubbles.
The Luer nozzle shall be situated centrally.
Material: Medical grade plastic; Polyethylene (PE), polypropylene (PP), polystyrene (PS).
Needle:
Material: Needle - stainless steel. Base and protective cap - Medical grade plastic.
Normal and thin walled.
External diameter expressed in gauge and millimetres.
Length expressed preferably in millimetres.
Size: 27G (approx. 0.4 x 13mm)
Needle tip: regular bevel.
Silicone coated to facilitate insertion.
Internationally recognized colour code system allows easy identification of the hypodermic needle's external diameter.
Cap:
The cap protects the needle, and preserves the sterility of the needle.
Material: polypropylene (PP).
Supplied with:
Manufacturer’s instructions for use may be printed onto the primary packaging of provided on a separate insert.
Languages: English, Spanish and French.
Accessories / Spare Parts / Consumables (available but not supplied):
N/A
Intended use:
For intramuscular (IM) injection: children, newborns.
To administer low volume injectables, such as Vitamin K 2mg/0.2 ml solution for newborns (0.040 to 0.100 ml volumes). This syringe type is typically used for insulin of tuberculin injections.
Safety process: The needle is for single use only. Use aseptic techniques.
Packaging and Labelling:
Primary packaging: Unit of use.
One (1) syringe packed in an individual sterilised peel pack made of paper and/of plastic.
Secondary packaging: Protected unit.
One (1) box of hundred (100) blister packed syringes.
Primary package label includes:
Device intity and intended purpose.
Manufacturer's product code of reference number.
Manufacturer identification.
Address of the manufacturing site.
EC Rep identification.
How the device should be used, maintained and stored.
Lot/Batch and MFD and EXP.
Any residual device risks, warnings, limitations of contraindications.
Symbols used according ISO 15223.
CE mark.
The word "sterile" (of equivalent harmonised symbol).
Sterilisation method (of equivalent harmonised symbol).
The words "for single use" (of equivalent harmonised symbol).
The words "check the package integrity before use", of similar warning.
The words "dispose after use", if space allows.
Secondary package label includes the number of units.
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 IIa device
Environmental Requirements:
ISO 14001: Environmental management system
| Pack Size | Avg. Price |
|---|---|
| Pack of 100 | $6.76 |
