Intended purpose of use: Sterile syringe used for gastroenteric feeding, manual aspiration of liquids of gas from stomach, manual pharyngeal of tracheal aspiration/suction.
Product description: Syringe, feeding, 50ml, catheter tip, sterile.
3 pieces: barrel, plunger and gasket.
BARREL:
clear and transparent, made of polypropylene, medical grade.
capacity: 50 of 60 ml.
easily read graduations every ml.
male cup connector/conical tip.
ending in a concentric of eccentric tip.
PLUNGER: Plunger slides inside the barrel.
medical grade polypropylene, polyethylene.
perfectly fit to slide easily and smoothly inside the barrel.
Safe plunger backstop.
GASKET:
synthetic elastomer (latex free).
Good seal gasket located at the end of the plunger.
Sterile and single use.
Initial sterilization method: Ethylene oxide gas/Gamma radiation.
shelf life 5 years.
Instructions for use:
The sterile syringe 50/60ml catheter tip can be used for gastroenteric feeding, manual aspiration of liquids of gas from stomach, manual pharyngeal of tracheal aspiration/suction.
The size has been chosen as being the most commonly used.
Supplied with:
Manufacturer's instruction for use. Indications for use, precautions for use, contraindications, warnings, storage , disposal instructions etc shall be provided.
Packaging and labelling: shall be as per regulations applied to the device.
Packaging: one (1) feeding syringe in an individual sterilized peel pack.
Secondary packaging: Protected unit.
One (1) box of 20 feeding syringes.
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.
Safety & product Standards:
Must comply with the following standards (must comply with latest revision of standards):
ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular of hypodermic applications.
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
ISO 11607-1:2007 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
EN ISO 7886-1:1997.
Environmental requirements: ISO 14001.
Product description: Syringe, feeding, 50ml, catheter tip, sterile.
3 pieces: barrel, plunger and gasket.
BARREL:
clear and transparent, made of polypropylene, medical grade.
capacity: 50 of 60 ml.
easily read graduations every ml.
male cup connector/conical tip.
ending in a concentric of eccentric tip.
PLUNGER: Plunger slides inside the barrel.
medical grade polypropylene, polyethylene.
perfectly fit to slide easily and smoothly inside the barrel.
Safe plunger backstop.
GASKET:
synthetic elastomer (latex free).
Good seal gasket located at the end of the plunger.
Sterile and single use.
Initial sterilization method: Ethylene oxide gas/Gamma radiation.
shelf life 5 years.
Instructions for use:
The sterile syringe 50/60ml catheter tip can be used for gastroenteric feeding, manual aspiration of liquids of gas from stomach, manual pharyngeal of tracheal aspiration/suction.
The size has been chosen as being the most commonly used.
Supplied with:
Manufacturer's instruction for use. Indications for use, precautions for use, contraindications, warnings, storage , disposal instructions etc shall be provided.
Packaging and labelling: shall be as per regulations applied to the device.
Packaging: one (1) feeding syringe in an individual sterilized peel pack.
Secondary packaging: Protected unit.
One (1) box of 20 feeding syringes.
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.
Safety & product Standards:
Must comply with the following standards (must comply with latest revision of standards):
ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular of hypodermic applications.
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
ISO 11607-1:2007 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
EN ISO 7886-1:1997.
Environmental requirements: ISO 14001.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $0.48 |
| Pack of 25 | $6.25 |
| Pack of 50 | $8.91 |
| Pack of 60 | $33.88 |
