Cutter, syringe hub

GENERAL DESCRIPTION
Syringe hub cutter

INTENDED USE
A device designed to cut a syringe to prevent syringe reuse. It typically includes a sharp metal cutting blade housed in a plastic container that receives the pieces of destroyed syringe. It is typically located in the vicinity of where the syringes are used, e.g., on the ward, in anaesthesia induction rooms, in an intensive care unit (ICU), accident and emergency (A&E) departments, and laboratories. This is a reusable device.

TECHNICAL SPECIFICATIONS
Cuts needles from syringes at the plastic hub, not through the metal part of the needle.
Including puncture resistant container.
Fill line indicator: Contains a fill line indicator marking the maximum filling volume at a level no greater than 85 % of the total capacity of the container and determined by the design of the container and considering the risk of sharps extending above the fill line.
Aperture: designed to minimize the potential for accidental sharps injuries during placement of sharps into the container.
Designed to restrict hand entry and removal of contents from the container.
Capable of being closed without the risk of sharps injury to the user.
Including a lid with closure feature, integrally attached to the container, which once activated cannot be reopened manually.
Container colour: yellow.
Single use product, to be only filled once.
Minimum capacity: 500 needles. Indicate actual capacity.

SUPPLIED WITH
Instructions for use in English.

ESTIMATED LIFE SPAN
Life span depends on utilization, once filled (approximately 500 needles) the device should no longer be used and disposed of in accordance with local hazardous goods guidelines.

WEIGHT AND VOLUME (Packaged)
Weight: 0.15 Kg.
Volume: 2.375 dm³.

RELATED PRODUCTS
S0782208, Safety box f.used syrgs/ndls 5lt/BOX-25
S0782213, Safety box f.used syrgs/ndls 5lt

QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.
- Supplier is certified for ISO 9001 Quality management systems – Requirements.

SAFETY AND PRODUCT STANDARDS
- ISO 15223 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

NOMENCLATURE
GMDN Code: 35385