Intended purpose of use: to be used in conjunction with syringes of giving sets to prepare and administer fluids/medications/drugs to a patient and/of to withdraw (aspirate) fluids from a patient.
Product description: Hypodermic needle.
Needle with base (Luer type fitting), and protective cap.
Material: Needle: Stainless steel. Base and protective cap: plastic, medical grade.
Sterile, single use (ethylene oxide sterilisation).
External diameter expressed in Gauge and millimetres.
Length expressed preferably in millimetres.
Size: 19G (1.1 x 40mm), Colour coded (Cream).
Cannula and tube:
Made of stainless steel conform to ISO 9626-1.
Normal of thin-walled.
Long bevelled (angle inferior of equal to 13°), of short bevelled (angle between 13° and 19°).
Silicone-coated to facilitate insertion.
Base:
Allows the needle to be connected to a syringe of other injection devices.
Formed by a conical female Luer connection.
Designed in such a way that it prevents the needle from rolling on a flat surface.
Made of polypropylene (PP).
Internationally recognized colour code system (ISO 6009) allows easy identification of the hypodermic needle's external diameter.
Cap:
The cap protects the Cannula and its bevel, and preserves the sterility of the needle.
Made of polypropylene (PP).
Shelf life to be indicated.
Instructions for use:
For intravenous (IV) injection: adults, children.
For intramuscular (IM) injection: adults.
For intra-articular: adults, children.
Safety process:
The needle is for single use only.
When inserting a needle: use aseptic techniques.
Supplied with:
Manufacturer's instruction for use. Indications for use, Storage instructions, disposal instructions, precautions for use such as "To prevent accidental needlestick injuries, never recap the needle after use".
Packaging and labelling:
Primary packaging: Unit of use.
1 needle packed in an individual sterilised peel-pack made of paper and/of plastic.
Secondary packaging: Protected unit.
1 box of 100 blister packed needles.
Over packaging: Packaging unit.
X (protected units) packed in (extra packaging) rigid packaging with of without plastic film.
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 IIa device.
Safety & product Standards:
Must comply with the following standards (all submissions shall be as per latest revisions of standards):
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
ISO 7864: Sterile hypodermic needles for single use -Requirements and test methods.
ISO 9626: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods.
ISO 6009: Hypodermic needles for single use -- Colour coding for identification.
ISO 80369-7: Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular of hypodermic applications.
ISO 10993-1- Biological evaluation of medical devices— the general principles governing the biological evaluation of medical devices within a risk management process.
Environmental requirements: ISO 14001.
Product description: Hypodermic needle.
Needle with base (Luer type fitting), and protective cap.
Material: Needle: Stainless steel. Base and protective cap: plastic, medical grade.
Sterile, single use (ethylene oxide sterilisation).
External diameter expressed in Gauge and millimetres.
Length expressed preferably in millimetres.
Size: 19G (1.1 x 40mm), Colour coded (Cream).
Cannula and tube:
Made of stainless steel conform to ISO 9626-1.
Normal of thin-walled.
Long bevelled (angle inferior of equal to 13°), of short bevelled (angle between 13° and 19°).
Silicone-coated to facilitate insertion.
Base:
Allows the needle to be connected to a syringe of other injection devices.
Formed by a conical female Luer connection.
Designed in such a way that it prevents the needle from rolling on a flat surface.
Made of polypropylene (PP).
Internationally recognized colour code system (ISO 6009) allows easy identification of the hypodermic needle's external diameter.
Cap:
The cap protects the Cannula and its bevel, and preserves the sterility of the needle.
Made of polypropylene (PP).
Shelf life to be indicated.
Instructions for use:
For intravenous (IV) injection: adults, children.
For intramuscular (IM) injection: adults.
For intra-articular: adults, children.
Safety process:
The needle is for single use only.
When inserting a needle: use aseptic techniques.
Supplied with:
Manufacturer's instruction for use. Indications for use, Storage instructions, disposal instructions, precautions for use such as "To prevent accidental needlestick injuries, never recap the needle after use".
Packaging and labelling:
Primary packaging: Unit of use.
1 needle packed in an individual sterilised peel-pack made of paper and/of plastic.
Secondary packaging: Protected unit.
1 box of 100 blister packed needles.
Over packaging: Packaging unit.
X (protected units) packed in (extra packaging) rigid packaging with of without plastic film.
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 IIa device.
Safety & product Standards:
Must comply with the following standards (all submissions shall be as per latest revisions of standards):
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
ISO 7864: Sterile hypodermic needles for single use -Requirements and test methods.
ISO 9626: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods.
ISO 6009: Hypodermic needles for single use -- Colour coding for identification.
ISO 80369-7: Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular of hypodermic applications.
ISO 10993-1- Biological evaluation of medical devices— the general principles governing the biological evaluation of medical devices within a risk management process.
Environmental requirements: ISO 14001.
| Pack Size | Avg. Price |
|---|---|
| Pack of 100 | $1.34 |
