"Product Description:
Syringe, two pieces: barrel with Luer Lock nozzle and piston or 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 or in combination e.g. Auto Disposable (AD), Reusable Prevention (RUP), Sharp Injury Prevention (SIP), Retractable Needle (RTN) may be considered. Mandatory product compliance standards ISO 7886 and ISO 23908. Primary package consists of an 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 or provided on a separate insert.
Languages: English, Spanish and French.
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 usONLY.
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/or plastic.
Primary package label includes:
Device identity and intended purpose.
Manufacturer's product code or 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 or contraindications.
Symbols used according ISO 15223.
CE mark.
The word ""sterile"" (or equivalent harmonised symbol).
Sterilisation method (or equivalent harmonised symbol).
The words ""for single use"" (or equivalent harmonised symbol).
The words ""check the package integrity before use"", or 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) or EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
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.
Safety and Product Standards (current versions of the following standards):
ISO 11135: Sterilization of health-care products - Ethylene oxide.
ISO 11607-1: Packaging for terminally sterilized medical devices - Part 1 : Requirements for materials, sterile barrier systems and packaging systems.
ISO 11607-2: Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes.
ISO 80369-1: Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements.
ISO 80369-7: Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for iscular or hypodermic applications.
ISO 7886-1: Sterile hypodermic syringes for single use - Part 1: Syringes for manual use.
ISO 10993: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Product and packaging complies with WHO PQS E08.
Environmental Requirements:
Use of other polymer instead of PVC.
ISO 14001: Environmental management systems."
Syringe, two pieces: barrel with Luer Lock nozzle and piston or 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 or in combination e.g. Auto Disposable (AD), Reusable Prevention (RUP), Sharp Injury Prevention (SIP), Retractable Needle (RTN) may be considered. Mandatory product compliance standards ISO 7886 and ISO 23908. Primary package consists of an 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 or provided on a separate insert.
Languages: English, Spanish and French.
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 usONLY.
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/or plastic.
Primary package label includes:
Device identity and intended purpose.
Manufacturer's product code or 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 or contraindications.
Symbols used according ISO 15223.
CE mark.
The word ""sterile"" (or equivalent harmonised symbol).
Sterilisation method (or equivalent harmonised symbol).
The words ""for single use"" (or equivalent harmonised symbol).
The words ""check the package integrity before use"", or 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) or EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
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.
Safety and Product Standards (current versions of the following standards):
ISO 11135: Sterilization of health-care products - Ethylene oxide.
ISO 11607-1: Packaging for terminally sterilized medical devices - Part 1 : Requirements for materials, sterile barrier systems and packaging systems.
ISO 11607-2: Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes.
ISO 80369-1: Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements.
ISO 80369-7: Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for iscular or hypodermic applications.
ISO 7886-1: Sterile hypodermic syringes for single use - Part 1: Syringes for manual use.
ISO 10993: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Product and packaging complies with WHO PQS E08.
Environmental Requirements:
Use of other polymer instead of PVC.
ISO 14001: Environmental management systems."
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $0.30 |
| Pack of 100 | $10.67 |
| Pack of 400 | $34.40 |
