IMPORTANT NOTE: These technical specifications are generic and may differ among suppliers.
Product Description:
Syringe, two pieces: barrel with Luer Lock nozzle and piston of three pieces barrel with luer nozzle, piston and stopper.
Without needle.
Safety Engineered Feature : The syringe has an auto-disable technology feature that passively activates upon starting administration of the prescribed injectable dose to prevent subsequent re-use of the syringe. Various mechanisms either standalone of in combination e.g. Auto Disposable (ADS), Reusable Prevention (RUP), Sharp Injury Prevention (SIP), Retractable Needle (RTN) may be considered. Mandatory product compliance standard ISO 7886 and ISO 23908. Primary package consists individual blister pack. Pre-sterilized.
Capacity: 20 ml.
Graduated scale on the barrel with 1.0 ml (minor) and 5.0 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 Lock nozzle shall be situated centrally.
Material: Medical grade plastic; Polyethylene (PE), polypropylene (PP), polystyrene (PS).
Sterile and disposable.
Single use.
Sterilization method: Ethylene oxide.
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:
Syringe is used with an injection needle with compatible luer fitting.
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 package integrity is compromised.
Packaging and Labelling:
Primary packaging:
One (1) syringe packed in an individual sterilised peel-pack made of paper and/of plastic.
Secondary packaging:
One (1) carton box of hundred (100) syringes to blister packs.
Primary package label includes:
Device identity 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 ""destroy 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
Environmental Requirements:
Use of other polymer instead of PVC.
ISO 14001: Environmental management systems
Product Description:
Syringe, two pieces: barrel with Luer Lock nozzle and piston of three pieces barrel with luer nozzle, piston and stopper.
Without needle.
Safety Engineered Feature : The syringe has an auto-disable technology feature that passively activates upon starting administration of the prescribed injectable dose to prevent subsequent re-use of the syringe. Various mechanisms either standalone of in combination e.g. Auto Disposable (ADS), Reusable Prevention (RUP), Sharp Injury Prevention (SIP), Retractable Needle (RTN) may be considered. Mandatory product compliance standard ISO 7886 and ISO 23908. Primary package consists individual blister pack. Pre-sterilized.
Capacity: 20 ml.
Graduated scale on the barrel with 1.0 ml (minor) and 5.0 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 Lock nozzle shall be situated centrally.
Material: Medical grade plastic; Polyethylene (PE), polypropylene (PP), polystyrene (PS).
Sterile and disposable.
Single use.
Sterilization method: Ethylene oxide.
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:
Syringe is used with an injection needle with compatible luer fitting.
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 package integrity is compromised.
Packaging and Labelling:
Primary packaging:
One (1) syringe packed in an individual sterilised peel-pack made of paper and/of plastic.
Secondary packaging:
One (1) carton box of hundred (100) syringes to blister packs.
Primary package label includes:
Device identity 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 ""destroy 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
Environmental Requirements:
Use of other polymer instead of PVC.
ISO 14001: Environmental management systems
| Pack Size | Avg. Price |
|---|---|
| Pack of 100 | $10.37 |
| Pack of 48 | $16.94 |
| Pack of 400 | $32.50 |
