Syringe,RUP,5ml,w/ndl,fixed,21G/BOX-100

General Description:
Syringe, with re-use prevention feature, 5ml, with fixed needle, 21Gx1 1/2” (0.8x40mm), disposable/BOX-100.

Intended use:
Vaccine reconstitution

Technical specifications:
Syringe Components: Syringe, two pieces: barrel with Luer nozzle and piston/plunger or three pieces: barrel with luer nozzle, stopper and piston/plunger.
Syringe capacity: 5ml
RUP description: The syringe has a reuse-prevention technology feature that either automatically activates upon or during administration of the intended dose or is activated by the user to prevent subsequent re-use of the syringe. The RUP feature is categorized as follows:
i) Activation: Passive (Type 1) or active (Type 2).
ii)Application: one plunger movement (Type A) or multiple Plunger movements (Type B). Syringes with re-use prevention feature conform to ISO 7886-4:2018.

Blister packed.

Syringe graduation: Graduated scale on the barrel, easy to read. Scale intervals of 0.2 or 0.5ml. Graduation lines of 1.0ml volume increment conform to ISO 7886-1:2017.
Syringe Barrel: sufficiently transparent to allow easy measurement of the volume contained in the syringe and detection of air bubbles. Length with a maximum usable capacity of at least 10% more than the nominal capacity conform to ISO 7886-1:2017. The Luer nozzle shall be situated centrally.
Syringe Material: medical grade plastic (Polyethylene (PE)/ polypropylene (PP)/ polystyrene (PS).
Needle: Fixed needle with protective cap conform to ISO 7864:2016.
Needle Material: Stainless steel conform to ISO 9626:2016.
Base and protective cap: medical grade plastic.
Measurements: External diameter expressed in Gauge and millimeters.
Length expressed in inch and millimeters.
Size selected: 21Gx1 1/2” (0.8x40mm).

Syringe with fixed needle: Disposable.

Sterile, (ethylene oxide sterilization and compiles to ISO 11135:2019)

Standards:
Product and packaging conform to ISO 7886-1:2017, ISO 7886-4:2018, ISO 7864:2016, ISO 9626:2016, ISO 11135:2019.
Product listed under WHO Performance Specification (PQS) Category E013 Hypodermic syringe with reuse prevention feature (RUP).

Quality management system (QMS): Products and manufacturer must be certified and comply with ISO 13485: 2016 requirements (or equivalent).
Marketing approval certificate: Product and manufacturer must conform to European Medical Device Regulation (EU) 2017/745 (or equivalent).

Packaging and labelling:
Primary packaging
Unit of use 1 syringe packed in an individual sterilized peel-pack made of paper and/or plastic.

Labelling on the primary packaging
Name and/or trade mark of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics. If the packaging is not transparent, it must bear a diagram (preferably actual size) showing the essential parts of the product and indicating the position of the product in the packaging.
Nominal capacity of the syringe.
External diameter and length of the needle, if included.
The words "for single use" (or equivalent harmonized symbol).
The symbol for "re-use prevention feature".
The word "sterile" (or equivalent harmonized symbol).
Sterilization method (or equivalent harmonized symbol).
Lot number prefixed by the word "LOT" (or equivalent harmonized symbol).
Expiry date (year and month), prefixed by the word "EXP" (or equivalent harmonized symbol).

Secondary packaging
Protected unit 1 box of 100 blister packed syringes.

Labelling on the secondary packaging
Name and/or trade mark and address of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics.
Nominal capacity of the syringe.
External diameter and length of the needle, if included.
The words "for single use" (or equivalent harmonized symbol).
The symbol for "re-use prevention feature".
The word "sterile" (or equivalent harmonized symbol).
Sterilization method (or equivalent harmonized symbol).
Lot number prefixed by the word "LOT" (or equivalent harmonized symbol).
Expiry date (year and month), prefixed by the word "EXP" (or equivalent harmonized symbol).
The number of units per secondary packaging.
A warning to check the integrity of the primary packaging before use.
A warning not to recap the needle (or equivalent symbol).
Information for handling, storage and disposal of syringe.
Manufacturer's instruction for use, including instructions appropriate to the re-use prevention feature.
Instructions for use shall be given either on the package or on a separate insert.

Related products
S0782208Safety box f.used syrgs/ndls 5lt/BOX-25

Useful links
http://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue /categorypage.aspx?id_cat=42