Gel, ultrasound, bottle, min. 250ml

GENERAL DESCRIPTION
Ultrasound coupling gel.

INTENDED USE
A non-sterile medium designed to be applied to a patient's unbroken skin surface to provide a coupling between an analytical device (e.g., ultrasound transducer, optical glucose monitoring system) and the patient, allowing for the emission and reception of signals (e.g., ultrasound, light) that pass through the skin during an examination. It is in the form of a non-sticky, fluid-like gel that may also assists the operator's ability to move the analytical device smoothly over the skin to better analyse the site of interest. It may be used by a healthcare professional or layperson. After application, this device cannot be reused.

TECHNICAL SPECIFICATIONS
Excellent transmission of ultrasound waves for a broad range of frequencies.
Sufficient viscosity to avoid dripping.
Hypoallergenic.
Reduces or eliminates static energy.
Excellent gliding properties.
Does not stain fabrics or damages equipment.
Non-sterile product.
Bottle size between 250 and 260 ml.

SUPPLIED WITH
Instructions for use in English, French and Spanish.

SHELF LIFE
36 months.

ENVIRONMENTAL CONDITIONS
Storage conditions: 10 - 30°C / 30 - 75% RH.

WEIGHT AND VOLUME (Packaged)
Weight: 293gr.
Volume: 0.550 dm³.

COMPONENT OF A KIT
S9902440, NBK, Clinic, Module 2, Consumables
S9902470, NBK, Hospital, Module 2, Consumables

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.

MARKET CLEARANCE AND DEVICE CLASSIFICATION
CE certified under the EU MDR 2017/745 as Class I device.

SAFETY AND PRODUCT STANDARDS
- ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process.

NOMENCLATURE
GMDN Code: 15321